Trial Outcomes & Findings for A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (NCT NCT03193190)
NCT ID: NCT03193190
Last Updated: 2025-11-21
Results Overview
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
341 participants
Primary outcome timeframe
Up to 33.3 months
Results posted on
2025-11-21
Participant Flow
A total of 341 participants with metastatic pancreatic ductal adenocarcinoma (PDAC) took part in the study from 05 Jul 2017 to 27 Feb 2025. The study included participants in 2 cohorts: Cohort 1: received no prior systemic therapy for metastatic PDAC \& Cohort 2: received 1 prior line of systemic therapy for PDAC. Multiple combination therapies were compared against common control(s) in Cohorts 1 and 2.
Eligible participants from both cohorts were assigned to one of several treatment arms in Stage 1. Cohort 2 participants with disease progression (PD), loss of clinical benefit, or unacceptable toxicity in Stage 1 were eligible for a different treatment combination in Stage 2. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
Participant milestones
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 milligrams/meter square (mg/m\^2), intravenous (IV) infusion and gemcitabine ,1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, subcutaneous (SC) injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
Participants received atezolizumab, 840 mg, and bevacizumab, 10 milligrams/kilograms (mg/kg), IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
Participants received AB928, 150 mg, orally, once daily (QD) on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 micrograms per kilogram (µg/kg), IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Every 3 Weeks (Q3W)
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Every 2 Weeks (Q2W)
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
35
|
9
|
25
|
16
|
42
|
31
|
25
|
25
|
16
|
15
|
71
|
16
|
15
|
0
|
0
|
0
|
|
Stage 1
Safety Population
|
32
|
9
|
25
|
15
|
41
|
30
|
23
|
23
|
15
|
14
|
66
|
15
|
14
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
35
|
9
|
25
|
16
|
42
|
31
|
25
|
25
|
16
|
15
|
71
|
16
|
15
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
6
|
1
|
|
Stage 2
Safety Population
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
6
|
1
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
6
|
1
|
Reasons for withdrawal
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 milligrams/meter square (mg/m\^2), intravenous (IV) infusion and gemcitabine ,1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, subcutaneous (SC) injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
Participants received atezolizumab, 840 mg, and bevacizumab, 10 milligrams/kilograms (mg/kg), IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
Participants received AB928, 150 mg, orally, once daily (QD) on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 micrograms per kilogram (µg/kg), IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Every 3 Weeks (Q3W)
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Every 2 Weeks (Q2W)
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
Arm Terminated by Sponsor
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Death
|
22
|
8
|
23
|
14
|
34
|
28
|
19
|
21
|
14
|
10
|
59
|
14
|
14
|
0
|
0
|
0
|
|
Stage 1
Lost to Follow-up
|
2
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Reason not Specified
|
1
|
0
|
0
|
1
|
0
|
1
|
2
|
2
|
0
|
1
|
3
|
0
|
1
|
0
|
0
|
0
|
|
Stage 1
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 1
Progressive Disease
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Study Terminated By Sponsor
|
3
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Withdrawal by Subject
|
6
|
0
|
1
|
0
|
2
|
0
|
3
|
2
|
2
|
4
|
9
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
4
|
1
|
|
Stage 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Stage 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
Baseline characteristics by cohort
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=35 Participants
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=9 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=25 Participants
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=16 Participants
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=42 Participants
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=31 Participants
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=25 Participants
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
n=25 Participants
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=16 Participants
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=15 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=71 Participants
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
n=16 Participants
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=15 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-64 years
|
15 Participants
n=68 Participants
|
6 Participants
n=76 Participants
|
13 Participants
n=48 Participants
|
11 Participants
n=33 Participants
|
26 Participants
n=225 Participants
|
11 Participants
n=192 Participants
|
9 Participants
n=24 Participants
|
20 Participants
n=94 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=10 Participants
|
49 Participants
n=5 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=94 Participants
|
193 Participants
n=4 Participants
|
|
Age, Customized
65-84 years
|
20 Participants
n=68 Participants
|
3 Participants
n=76 Participants
|
12 Participants
n=48 Participants
|
5 Participants
n=33 Participants
|
16 Participants
n=225 Participants
|
20 Participants
n=192 Participants
|
16 Participants
n=24 Participants
|
5 Participants
n=94 Participants
|
8 Participants
n=6 Participants
|
6 Participants
n=10 Participants
|
22 Participants
n=5 Participants
|
8 Participants
n=10 Participants
|
7 Participants
n=94 Participants
|
148 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=68 Participants
|
4 Participants
n=76 Participants
|
7 Participants
n=48 Participants
|
8 Participants
n=33 Participants
|
12 Participants
n=225 Participants
|
11 Participants
n=192 Participants
|
14 Participants
n=24 Participants
|
11 Participants
n=94 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
28 Participants
n=5 Participants
|
9 Participants
n=10 Participants
|
7 Participants
n=94 Participants
|
134 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=68 Participants
|
5 Participants
n=76 Participants
|
18 Participants
n=48 Participants
|
8 Participants
n=33 Participants
|
30 Participants
n=225 Participants
|
20 Participants
n=192 Participants
|
11 Participants
n=24 Participants
|
14 Participants
n=94 Participants
|
11 Participants
n=6 Participants
|
10 Participants
n=10 Participants
|
43 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
8 Participants
n=94 Participants
|
207 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
5 Participants
n=225 Participants
|
0 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=94 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=94 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=68 Participants
|
9 Participants
n=76 Participants
|
23 Participants
n=48 Participants
|
16 Participants
n=33 Participants
|
36 Participants
n=225 Participants
|
30 Participants
n=192 Participants
|
25 Participants
n=24 Participants
|
24 Participants
n=94 Participants
|
16 Participants
n=6 Participants
|
15 Participants
n=10 Participants
|
68 Participants
n=5 Participants
|
16 Participants
n=10 Participants
|
14 Participants
n=94 Participants
|
325 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=225 Participants
|
1 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=94 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
1 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=94 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=68 Participants
|
1 Participants
n=76 Participants
|
5 Participants
n=48 Participants
|
8 Participants
n=33 Participants
|
8 Participants
n=225 Participants
|
12 Participants
n=192 Participants
|
11 Participants
n=24 Participants
|
6 Participants
n=94 Participants
|
8 Participants
n=6 Participants
|
4 Participants
n=10 Participants
|
21 Participants
n=5 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=94 Participants
|
105 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=94 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
2 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=225 Participants
|
1 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=94 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=94 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=68 Participants
|
4 Participants
n=76 Participants
|
16 Participants
n=48 Participants
|
7 Participants
n=33 Participants
|
30 Participants
n=225 Participants
|
15 Participants
n=192 Participants
|
14 Participants
n=24 Participants
|
19 Participants
n=94 Participants
|
7 Participants
n=6 Participants
|
9 Participants
n=10 Participants
|
43 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=94 Participants
|
203 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=94 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=68 Participants
|
1 Participants
n=76 Participants
|
2 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
3 Participants
n=225 Participants
|
3 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=94 Participants
|
20 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 33.3 monthsPopulation: Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=32 Participants
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=9 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=25 Participants
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=15 Participants
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=41 Participants
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=30 Participants
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=23 Participants
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
n=23 Participants
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=14 Participants
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=66 Participants
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
n=15 Participants
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
|
37.5 percentage of participants
Interval 21.1 to 56.31
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
48.0 percentage of participants
Interval 27.8 to 68.69
|
26.7 percentage of participants
Interval 7.79 to 55.1
|
31.7 percentage of participants
Interval 18.08 to 48.09
|
30.0 percentage of participants
Interval 14.73 to 49.4
|
8.7 percentage of participants
Interval 1.07 to 28.04
|
0 percentage of participants
Interval 0.0 to 14.82
|
0 percentage of participants
Interval 0.0 to 23.16
|
0 percentage of participants
Interval 0.0 to 23.16
|
6.1 percentage of participants
Interval 1.68 to 14.8
|
0 percentage of participants
Interval 0.0 to 21.8
|
7.1 percentage of participants
Interval 0.18 to 33.87
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 33.3 monthsPopulation: Safety population included all participants who received any amount of study treatment.
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Outcome measures
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=32 Participants
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=9 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=25 Participants
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=15 Participants
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=41 Participants
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=30 Participants
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=23 Participants
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
n=23 Participants
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=15 Participants
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=66 Participants
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
n=15 Participants
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
n=14 Participants
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
n=6 Participants
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
n=1 Participants
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
32 Participants
|
9 Participants
|
24 Participants
|
15 Participants
|
41 Participants
|
30 Participants
|
22 Participants
|
23 Participants
|
15 Participants
|
14 Participants
|
65 Participants
|
15 Participants
|
14 Participants
|
14 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 33.3 monthsPopulation: Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (K-M) method was used to estimate PFS.
Outcome measures
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=32 Participants
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=9 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=25 Participants
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=15 Participants
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=41 Participants
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=30 Participants
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=23 Participants
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
n=23 Participants
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=14 Participants
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=66 Participants
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
n=15 Participants
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1
|
6.11 months
Interval 5.13 to 9.92
|
4.04 months
Interval 3.02 to 6.97
|
7.18 months
Interval 5.03 to 9.82
|
8.21 months
Interval 5.91 to 11.1
|
5.82 months
Interval 4.4 to 7.52
|
5.39 months
Interval 4.17 to 8.21
|
2.76 months
Interval 1.45 to 5.52
|
2.53 months
Interval 1.77 to 4.04
|
1.64 months
Interval 1.41 to 1.87
|
1.28 months
Interval 1.15 to 1.84
|
1.51 months
Interval 1.38 to 2.56
|
1.38 months
Interval 1.38 to 2.66
|
1.46 months
Interval 1.31 to 1.58
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 33.3 monthsPopulation: Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS.
Outcome measures
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=32 Participants
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=9 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=25 Participants
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=15 Participants
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=41 Participants
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=30 Participants
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=23 Participants
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
n=23 Participants
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=14 Participants
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=66 Participants
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
n=15 Participants
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Overall Survival (OS), as Determined by Investigator According to RECIST v1.1
|
14.55 months
Interval 9.99 to 16.16
|
9.03 months
Interval 3.42 to 16.13
|
13.34 months
Interval 9.1 to 15.21
|
16.49 months
Interval 9.59 to 19.71
|
13.34 months
Interval 9.43 to 21.59
|
11.20 months
Interval 8.21 to 17.94
|
6.77 months
Interval 6.34 to 9.66
|
8.31 months
Interval 4.11 to 13.04
|
4.47 months
Interval 3.12 to 7.06
|
4.24 months
Interval 1.84 to 6.97
|
7.06 months
Interval 4.07 to 8.38
|
4.70 months
Interval 3.81 to 11.04
|
7.33 months
Interval 4.86 to 11.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
OS was defined as the time from randomization to death from any cause. OS rate at 6 months was defined as the percentage of participants who did not experience death from any cause at 6 months from randomization. K-M method was used to estimate OS. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=32 Participants
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=9 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=25 Participants
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=15 Participants
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=41 Participants
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=30 Participants
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=23 Participants
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
n=23 Participants
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=14 Participants
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=66 Participants
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
n=15 Participants
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: OS Rate at Month 6
|
87.07 percentage of participants
Interval 75.23 to 98.91
|
55.56 percentage of participants
Interval 23.09 to 88.02
|
83.48 percentage of participants
Interval 68.67 to 98.28
|
80.00 percentage of participants
Interval 59.76 to 100.0
|
72.55 percentage of participants
Interval 58.72 to 86.37
|
86.67 percentage of participants
Interval 74.5 to 98.83
|
78.76 percentage of participants
Interval 60.06 to 97.46
|
53.45 percentage of participants
Interval 30.72 to 76.19
|
27.78 percentage of participants
Interval 1.17 to 54.39
|
41.96 percentage of participants
Interval 14.01 to 69.91
|
51.97 percentage of participants
Interval 39.29 to 64.65
|
43.33 percentage of participants
Interval 17.35 to 69.32
|
50.00 percentage of participants
Interval 23.81 to 76.19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 33.3 monthsPopulation: Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment. Overall number analyzed included participants with OR i.e responders.
DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate DOR.
Outcome measures
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=12 Participants
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=5 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=12 Participants
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=4 Participants
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=13 Participants
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=9 Participants
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=2 Participants
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=4 Participants
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=1 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST v1.1
|
5.40 months
Interval 3.94 to 8.21
|
3.35 months
Interval 2.56 to
The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
|
8.18 months
Interval 6.34 to 8.74
|
4.85 months
Interval 2.86 to
The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
|
4.47 months
Interval 3.58 to 10.12
|
5.65 months
Interval 4.53 to 10.84
|
3.37 months
Interval 2.83 to
The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
|
—
|
—
|
—
|
8.15 months
Interval 5.32 to
The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
|
—
|
6.14 months
The 95% CI was not estimable due to an insufficient number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 33.3 monthsPopulation: Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=32 Participants
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=9 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=25 Participants
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=15 Participants
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=41 Participants
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=30 Participants
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=23 Participants
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
n=23 Participants
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=14 Participants
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=66 Participants
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
n=15 Participants
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=14 Participants
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST v1.1
|
81.3 percentage of participants
Interval 63.56 to 92.79
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
64.0 percentage of participants
Interval 42.52 to 82.03
|
66.7 percentage of participants
Interval 38.38 to 88.18
|
61.0 percentage of participants
Interval 44.5 to 75.8
|
66.7 percentage of participants
Interval 47.19 to 82.71
|
30.4 percentage of participants
Interval 13.21 to 52.92
|
34.8 percentage of participants
Interval 16.38 to 57.27
|
0 percentage of participants
Interval 0.0 to 23.16
|
0 percentage of participants
Interval 0.0 to 23.16
|
18.2 percentage of participants
Interval 9.76 to 29.61
|
0 percentage of participants
Interval 0.0 to 21.8
|
7.1 percentage of participants
Interval 0.18 to 33.87
|
—
|
—
|
—
|
Adverse Events
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Serious events: 13 serious events
Other events: 32 other events
Deaths: 23 deaths
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
Serious events: 8 serious events
Other events: 9 other events
Deaths: 8 deaths
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
Serious events: 17 serious events
Other events: 23 other events
Deaths: 23 deaths
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
Serious events: 4 serious events
Other events: 15 other events
Deaths: 14 deaths
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
Serious events: 19 serious events
Other events: 40 other events
Deaths: 34 deaths
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
Serious events: 12 serious events
Other events: 30 other events
Deaths: 28 deaths
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
Serious events: 10 serious events
Other events: 21 other events
Deaths: 19 deaths
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Serious events: 12 serious events
Other events: 23 other events
Deaths: 21 deaths
Stage 1 Cohort 2: Atezolizumab + BL-8040
Serious events: 4 serious events
Other events: 15 other events
Deaths: 14 deaths
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Serious events: 8 serious events
Other events: 13 other events
Deaths: 11 deaths
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Serious events: 30 serious events
Other events: 65 other events
Deaths: 60 deaths
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Serious events: 7 serious events
Other events: 15 other events
Deaths: 14 deaths
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Serious events: 2 serious events
Other events: 14 other events
Deaths: 14 deaths
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Serious events: 7 serious events
Other events: 13 other events
Deaths: 14 deaths
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=32 participants at risk
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=9 participants at risk
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=25 participants at risk
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=15 participants at risk
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=41 participants at risk
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=30 participants at risk
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=23 participants at risk
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
n=23 participants at risk
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=15 participants at risk
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=14 participants at risk
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=66 participants at risk
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
n=15 participants at risk
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=14 participants at risk
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
n=14 participants at risk
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
n=6 participants at risk
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
n=1 participants at risk
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Embolism
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Pancreatic duct obstruction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Chest pain
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Chills
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Death
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.4%
4/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Biliary tract infection
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Cellulitis
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Arthritis infective
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Sweat gland infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Sepsis
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Septic shock
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Embolic cerebellar infarction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Product Issues
Device dislocation
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
3/32 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Middle cerebral artery stroke
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pseudocellulitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Angiodysplasia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
Other adverse events
| Measure |
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
n=32 participants at risk
Participants received nab-paclitaxel, 125 mg/m\^2, IV infusion and gemcitabine, 1000 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
n=9 participants at risk
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
n=25 participants at risk
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + AB928
n=15 participants at risk
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m\^2, and gemcitabine, 1000 mg/m\^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
n=41 participants at risk
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
n=30 participants at risk
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Control (5-fluorouracil + Leucovorin + Oxaliplatin [mFOLFOX6])
n=23 participants at risk
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m\^2 and leucovorin, 400 mg/m\^2 as IV infusion, and 5-fluorouracil, 400 mg/m\^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m\^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
n=23 participants at risk
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m\^2 and gemcitabine, 1000 mg/m\^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=15 participants at risk
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
n=14 participants at risk
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=66 participants at risk
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
n=15 participants at risk
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
n=14 participants at risk
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
n=14 participants at risk
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
n=6 participants at risk
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
|
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
n=1 participants at risk
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
43.8%
14/32 • Number of events 15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
44.4%
4/9 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
10/25 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
60.0%
9/15 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
31.7%
13/41 • Number of events 19 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
6/30 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.4%
4/23 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.1%
6/23 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.1%
8/66 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.2%
10/32 • Number of events 13 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.0%
4/25 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.1%
7/41 • Number of events 13 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.0%
9/30 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.1%
6/23 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.4%
4/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
4/32 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
5/30 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
34.8%
8/23 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Palpitations
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Central serous chorioretinopathy
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Dry eye
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Halo vision
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Photopsia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Retinal tear
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Vision blurred
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.1%
4/66 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.9%
7/32 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
5/25 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.8%
11/41 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
4/30 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
5/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.6%
9/66 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.0%
4/25 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
1/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
12/32 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
5/25 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.4%
10/41 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
10/30 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.4%
7/23 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.7%
5/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
5/15 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
15.2%
10/66 • Number of events 13 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
6/15 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
50.0%
7/14 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.6%
13/32 • Number of events 16 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
36.0%
9/25 • Number of events 14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
36.6%
15/41 • Number of events 18 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
36.7%
11/30 • Number of events 13 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.4%
4/23 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
35.7%
5/14 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
11/66 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
42.9%
6/14 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
9.4%
3/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
4/30 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.6%
5/66 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
2/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.6%
7/66 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
9.4%
3/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.0%
4/25 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
4/32 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.2%
5/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.7%
5/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
8/32 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
10/25 • Number of events 15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
19.5%
8/41 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
6/30 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.4%
7/23 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.4%
4/23 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
35.7%
5/14 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
11/66 • Number of events 14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.6%
4/14 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.6%
4/14 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Asthenia
|
12.5%
4/32 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
5/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.6%
6/41 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.1%
6/23 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.4%
4/23 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.6%
5/66 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
53.1%
17/32 • Number of events 20 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
77.8%
7/9 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
36.0%
9/25 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
46.7%
7/15 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
51.2%
21/41 • Number of events 23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
53.3%
16/30 • Number of events 19 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
43.5%
10/23 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
39.1%
9/23 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
5/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
50.0%
7/14 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.3%
20/66 • Number of events 23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
6/15 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
64.3%
9/14 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Chills
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.2%
5/41 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
66.7%
10/15 • Number of events 14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
42.9%
6/14 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Face oedema
|
3.1%
1/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Fatigue
|
56.2%
18/32 • Number of events 22 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
55.6%
5/9 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
44.0%
11/25 • Number of events 16 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
56.1%
23/41 • Number of events 25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
23.3%
7/30 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.7%
5/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
39.1%
9/23 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
66.7%
10/15 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
35.7%
5/14 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
31.8%
21/66 • Number of events 22 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
5/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
42.9%
6/14 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Feeling cold
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Feeling hot
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Generalised oedema
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Hernia pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Influenza like illness
|
15.6%
5/32 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Injection site pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Injection site reaction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
44.4%
4/9 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
73.3%
11/15 • Number of events 21 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Malaise
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
4/30 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Mucosal inflammation
|
9.4%
3/32 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Nodule
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Oedema
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.1%
4/66 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Oedema peripheral
|
34.4%
11/32 • Number of events 17 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
44.4%
4/9 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.0%
7/25 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
39.0%
16/41 • Number of events 19 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.0%
9/30 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.4%
7/23 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
22/66 • Number of events 26 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
35.7%
5/14 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Peripheral swelling
|
3.1%
1/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
COVID-19
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.8%
4/41 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Cellulitis
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Gingivitis
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Hordeolum
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Pyrexia
|
34.4%
11/32 • Number of events 13 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
55.6%
5/9 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
34.1%
14/41 • Number of events 19 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.7%
5/23 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
35.7%
5/14 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.6%
7/66 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
46.7%
7/15 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
71.4%
10/14 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Temperature intolerance
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Mucosal infection
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Nail infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Oral candidiasis
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.6%
4/14 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Vascular access site infection
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
8/32 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.0%
6/25 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
6/15 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.1%
7/41 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
46.7%
14/30 • Number of events 15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.1%
6/23 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.6%
7/66 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
5/15 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
35.7%
5/14 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Aspartate aminotransferase decreased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
21.9%
7/32 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
44.4%
4/9 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
5/25 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
6/15 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.1%
7/41 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
36.7%
11/30 • Number of events 14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.4%
7/23 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
50.0%
7/14 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.1%
8/66 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
6/15 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
42.9%
6/14 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.2%
5/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.4%
7/23 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.1%
8/66 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
35.7%
5/14 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood bilirubin increased
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.4%
4/23 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.6%
4/14 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood creatine increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood creatinine increased
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.1%
4/66 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Liver function test increased
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
2/6 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.4%
3/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.8%
4/41 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.1%
6/66 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.6%
5/66 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.4%
3/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.6%
4/14 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.6%
7/66 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Neutrophil count decreased
|
18.8%
6/32 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
44.4%
4/9 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
32.0%
8/25 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
5/15 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.4%
10/41 • Number of events 16 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
60.0%
18/30 • Number of events 22 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
34.8%
8/23 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Platelet count decreased
|
12.5%
4/32 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.0%
4/25 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.8%
11/41 • Number of events 17 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
53.3%
16/30 • Number of events 20 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.4%
4/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Urine output decreased
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Weight decreased
|
15.6%
5/32 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.0%
6/25 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.1%
7/41 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
5/30 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Weight increased
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
White blood cell count decreased
|
12.5%
4/32 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.8%
4/41 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
10/30 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.7%
5/23 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.6%
13/32 • Number of events 14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
10/25 • Number of events 14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
46.7%
7/15 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
34.1%
14/41 • Number of events 15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.0%
9/30 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
39.1%
9/23 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.2%
14/66 • Number of events 15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.6%
4/14 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.8%
4/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.5%
4/32 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.2%
5/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.7%
5/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.1%
4/66 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
9.4%
3/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.0%
4/25 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.8%
4/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Headache
|
12.5%
4/32 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
5/25 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.8%
4/41 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.6%
5/32 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.0%
6/25 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.2%
5/41 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
4/30 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
17.4%
4/23 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.2%
16/66 • Number of events 18 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.6%
6/41 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
5/30 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.7%
5/23 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.6%
5/66 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
1/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
11/66 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.2%
5/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
8/32 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
10/25 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.8%
11/41 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
4/30 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.1%
6/23 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Neurotoxicity
|
9.4%
3/32 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
8/32 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.2%
5/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
4/30 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Depression
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Insomnia
|
21.9%
7/32 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.6%
6/41 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.1%
4/66 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Chromaturia
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.8%
4/41 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.0%
4/25 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.9%
7/32 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.0%
6/25 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
19.5%
8/41 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
4/30 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.1%
6/66 • Number of events 10 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.6%
4/14 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.6%
7/66 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.8%
6/32 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.0%
6/25 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
29.3%
12/41 • Number of events 12 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.1%
8/66 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.0%
6/25 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.6%
6/41 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.8%
14/32 • Number of events 14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.0%
4/25 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
4/15 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
34.1%
14/41 • Number of events 14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.0%
9/30 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
34.8%
8/23 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.2%
2/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.2%
5/41 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
5/30 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.6%
5/32 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
5/25 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
40.0%
6/15 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
36.6%
15/41 • Number of events 22 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
30.0%
9/30 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.7%
5/23 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.4%
3/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
26.7%
8/30 • Number of events 8 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
20.0%
3/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Embolism
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.0%
2/66 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Hypertension
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
36.0%
9/25 • Number of events 13 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.0%
3/23 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.6%
5/66 • Number of events 6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
5/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
8/32 • Number of events 9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.0%
7/25 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
5/15 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
24.4%
10/41 • Number of events 11 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
4/30 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
9.8%
4/41 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.1%
4/66 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
53.3%
8/15 • Number of events 25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Stoma site discomfort
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
4/32 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
44.4%
4/9 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.0%
3/25 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
12.2%
5/41 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
5/30 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.7%
2/23 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
68.2%
45/66 • Number of events 50 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
4/32 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.6%
6/41 • Number of events 7 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
10.0%
3/30 • Number of events 5 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.5%
3/66 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
13.3%
2/15 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
28.6%
4/14 • Number of events 4 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/32 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.4%
3/32 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/41 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.0%
1/25 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
2/30 • Number of events 3 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
1.5%
1/66 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.1%
1/32 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/9 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
8.0%
2/25 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
6.7%
1/15 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
4.3%
1/23 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
6.2%
2/32 • Number of events 2 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/25 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/30 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/23 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/66 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/15 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/14 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/6 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
0.00%
0/1 • Up to 33.3 months
Safety population included all participants who received any amount of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER