Trial Outcomes & Findings for A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors (NCT NCT02501096)
NCT ID: NCT02501096
Last Updated: 2023-07-20
Results Overview
MTD was confirmed if no more than 3 participants experience dose-limiting toxicities(DLTs)during first 3 weeks (Cycle 1) of treatment.If MTD was not confirmed at dose level,then enrollment was proceeded to next lower dose level.Sponsor and investigators reviewed all participants' safety;clinical data to jointly determine RP2D of combination of treatment.DLT may be any of following: hematological/nonhematological toxicities considered to be at least possibly related to Lenvatinib/pembrolizumab occurring during Cycle 1;Failure to administer greater than or equal to (\>=) 75 percent (%) of planned dosage of lenvatinib as result of treatment-related toxicity during Cycle 1;Who discontinue treatment due to treatment-related toxicity.Greater than 2 week delay in starting Cycle 2 because of treatment-related toxicity,even if toxicity does not meet DLT criteria.Toxicity was evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03(NCI CTCAE v 4.03).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
357 participants
Primary outcome timeframe
Cycle 1 (21 days)
Results posted on
2023-07-20
Participant Flow
Participants took part in the study at 62 investigative sites in the United States, Spain and Norway from 22 July 2015 to 11 July 2022.
Total of 454 participants were screened, of which 357 were enrolled/treated. A total of 13 participants were enrolled in Phase 1b, of which 3 participants received lenvatinib 24 mg/day+pembrolizumab 200 mg and 10 participants received lenvatinib 20 mg/day+pembrolizumab 200 mg while in Phase 2, 344 participants received lenvatinib 20 mg/day+pembrolizumab 200 mg. As planned,Phase 1b/2 data for participants who received lenvatinib 20 mg/day+pembrolizumab 200 mg was combined and presented together.
Participant milestones
| Measure |
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
Participants with Renal Cell Carcinoma (RCC) received lenvatinib 24 milligram per day (mg/day), capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, once every three weeks (Q3W) on Day 1 of each cycle (cycle length=21 days) until disease progression (PD), development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
Participant with Non-small Cell Lung Cancer (NSCLC) received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
Participants with Endometrial Carcinoma (EC) received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
Participants with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
Participants with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
Participants with Squamous Cell Carcinoma of Head and Neck (HNSCC) received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with Urothelial Carcinoma (UC) received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
124
|
145
|
21
|
21
|
22
|
20
|
1
|
|
Overall Study
Phase 1b Participants Who Received, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg.
|
0
|
0
|
2
|
6
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Phase 2 Participants Who Received, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg
|
0
|
0
|
122
|
139
|
20
|
20
|
22
|
20
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
124
|
145
|
21
|
21
|
22
|
20
|
1
|
Reasons for withdrawal
| Measure |
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
Participants with Renal Cell Carcinoma (RCC) received lenvatinib 24 milligram per day (mg/day), capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, once every three weeks (Q3W) on Day 1 of each cycle (cycle length=21 days) until disease progression (PD), development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
Participant with Non-small Cell Lung Cancer (NSCLC) received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
Participants with Endometrial Carcinoma (EC) received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
Participants with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
Participants with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
Participants with Squamous Cell Carcinoma of Head and Neck (HNSCC) received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with Urothelial Carcinoma (UC) received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
7
|
13
|
2
|
2
|
2
|
3
|
0
|
|
Overall Study
Survival follow-up discontinued by sponsor
|
0
|
0
|
29
|
58
|
3
|
2
|
2
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
88
|
74
|
15
|
16
|
15
|
16
|
1
|
Baseline Characteristics
A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
n=2 Participants
Participants with RCC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=1 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
n=124 Participants
Participants with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
n=145 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
n=21 Participants
Participants with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
n=21 Participants
Participants with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
n=22 Participants
Participants with HNSCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
n=20 Participants
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
174 Participants
|
|
Age, Customized
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
183 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
182 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
113 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
175 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
128 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
21 Participants
n=3 Participants
|
18 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
331 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
19 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
125 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
18 Participants
n=30 Participants
|
20 Participants
n=3 Participants
|
19 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
312 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: The MTD analysis set included all participants who completed Cycle 1 of treatment in Phase 1b or discontinued early due to DLT.
MTD was confirmed if no more than 3 participants experience dose-limiting toxicities(DLTs)during first 3 weeks (Cycle 1) of treatment.If MTD was not confirmed at dose level,then enrollment was proceeded to next lower dose level.Sponsor and investigators reviewed all participants' safety;clinical data to jointly determine RP2D of combination of treatment.DLT may be any of following: hematological/nonhematological toxicities considered to be at least possibly related to Lenvatinib/pembrolizumab occurring during Cycle 1;Failure to administer greater than or equal to (\>=) 75 percent (%) of planned dosage of lenvatinib as result of treatment-related toxicity during Cycle 1;Who discontinue treatment due to treatment-related toxicity.Greater than 2 week delay in starting Cycle 2 because of treatment-related toxicity,even if toxicity does not meet DLT criteria.Toxicity was evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03(NCI CTCAE v 4.03).
Outcome measures
| Measure |
Phase 1b: All Participants
n=13 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib
MTD
|
20 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib
RP2D
|
20 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: The MTD analysis set included all participants who completed Cycle 1 of treatment in Phase 1b or discontinued early due to DLT.
A DLT was defined as any of the following: any of the hematological or nonhematological toxicities considered to be at least possibly related to lenvatinib and/or pembrolizumab occurring during Cycle 1. Failure to administer \>=75% of the planned dosage of lenvatinib as a result of treatment-related toxicity during Cycle 1. Participants who discontinue treatment due to treatment-related toxicity. Greater than 2 week delay in starting Cycle 2 because of a treatment-related toxicity, even if the toxicity does not meet DLT criteria. Toxicity was evaluated as per NCI CTCAE v 4.03.
Outcome measures
| Measure |
Phase 1b: All Participants
n=2 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=1 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=1 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=6 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=2 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=1 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: The full analysis set (FAS) included all participants who entered the study treatment period.
ORR was defined as the percentage of participants whose best overall response (BOR) was immune related complete response (irCR) or immune related partial response (irPR) based on investigator assessment according to irRECIST version 1.1. irCR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). irPR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Phase 1b: All Participants
n=124 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=145 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=21 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=21 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=22 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=20 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Based on Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) Version 1.1 at Week 24
|
39.5 percentage of participants
Interval 30.9 to 48.7
|
56.6 percentage of participants
Interval 48.1 to 64.8
|
47.6 percentage of participants
Interval 25.7 to 70.2
|
23.8 percentage of participants
Interval 8.2 to 47.2
|
31.8 percentage of participants
Interval 13.9 to 54.9
|
25.0 percentage of participants
Interval 8.7 to 49.1
|
0 percentage of participants
Here, 95% CI could not be estimated as insufficient number of participants were available for analysis in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first dose up to 30 days after the last dose of study drugs (Up to 74 months)Population: The safety analysis set included all participants who received at least one dose of study drug.
TEAE: adverse event (AE) emerged during treatment, having been absent at pretreatment or reemerged during treatment, present at pretreatment but stopped before treatment or worsened in severity during treatment relative to pretreatment state, when AE is continuous. AE: any untoward medical occurrence in participant administered an investigational product. TEAEs were based on participants laboratory tests, regular measurement of vital signs, echocardiograms/multigated acquisition scans to assess left ventricular ejection fraction and electrocardiograms parameter values. TESAE: any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; a congenital anomaly/birth defect or was medically important due to reasons other than above criteria.
Outcome measures
| Measure |
Phase 1b: All Participants
n=2 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=1 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=124 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=145 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=21 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=21 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=22 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
n=20 Participants
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
2 Participants
|
1 Participants
|
124 Participants
|
145 Participants
|
21 Participants
|
21 Participants
|
22 Participants
|
20 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
1 Participants
|
1 Participants
|
73 Participants
|
81 Participants
|
12 Participants
|
15 Participants
|
12 Participants
|
17 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of first dose of study drug administration until immune related (irPD), development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months)Population: The FAS included all participants who entered the study treatment period.
ORR was defined as the percentage of participants whose BOR was irCR or irPR according to irRECIST version 1.1. irCR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. irPR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Phase 1b: All Participants
n=124 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=145 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=21 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=21 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=22 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=20 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Based on irRECIST Version 1.1
|
40.3 percentage of participants
Interval 31.6 to 49.5
|
63.4 percentage of participants
Interval 55.1 to 71.3
|
47.6 percentage of participants
Interval 25.7 to 70.2
|
23.8 percentage of participants
Interval 8.2 to 47.2
|
40.9 percentage of participants
Interval 20.7 to 63.6
|
25.0 percentage of participants
Interval 8.7 to 49.1
|
NA percentage of participants
Here, number and 95% CI could not be estimated as insufficient number of participants were available for analysis in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first dose of study drug administration to date of irPD or date of death, whichever occurred first (up to 73 months)Population: The FAS included all participants who entered the study treatment period.
PFS was defined as the time from the first dose date to the date of irPD or date of death (whichever occurred first) according to irRECIST version 1.1. irPD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression).
Outcome measures
| Measure |
Phase 1b: All Participants
n=124 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=145 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=21 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=21 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=22 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=20 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) Based on irRECIST Version 1.1
|
7.5 months
Interval 5.3 to 9.7
|
14.1 months
Interval 11.6 to 18.4
|
5.5 months
Interval 2.6 to 15.8
|
5.4 months
Interval 2.3 to 7.4
|
4.4 months
Interval 4.0 to 9.8
|
5.4 months
Interval 1.3 to 42.3
|
1.35 months
Here, 95% CI could not be estimated as insufficient number of participants were available for analysis in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose until death from any cause, up to 73 monthsPopulation: The FAS included all participants who entered the study treatment period.
OS was defined as the time from the first dose date to the date of death from any cause.
Outcome measures
| Measure |
Phase 1b: All Participants
n=124 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=145 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=21 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=21 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=22 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=20 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
19.9 months
Interval 16.2 to 25.9
|
32.2 months
Interval 29.8 to 55.8
|
25.4 months
Interval 8.6 to 39.5
|
11.4 months
Interval 3.6 to 23.3
|
16.2 months
Interval 8.6 to 31.8
|
6.1 months
Interval 2.4 to 30.1
|
16.56 months
Here, 95% CI could not be estimated as insufficient number of participants were available for analysis in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of the study drug until irPD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months)Population: The FAS included all participants who entered the study treatment period.
DCR: percentage of participants with a confirmed irCR, irPR, or ir-stable disease (SD) (duration of irSD greater than or equal to \[\>=\] 5 weeks). DCR was assessed on irRECIST v1.1. irCR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have reduction in their short axis to \<10 mm. irPR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference baseline sum of longest diameter. irSD: neither sufficient shrinkage to qualify for irPR nor sufficient increase to qualify for irPD, taking as reference smallest sum diameters while on study. irPD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Phase 1b: All Participants
n=124 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=145 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=21 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=21 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=22 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=20 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) Based on irRECIST Version 1.1
|
84.7 percentage of participants
Interval 77.1 to 90.5
|
93.8 percentage of participants
Interval 88.5 to 97.1
|
81.0 percentage of participants
Interval 58.1 to 94.6
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
90.9 percentage of participants
Interval 70.8 to 98.9
|
70.0 percentage of participants
Interval 45.7 to 88.1
|
NA percentage of participants
Here, Number and 95% CI could not be estimated as insufficient number of participants were available for analysis in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose date until irPD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months)Population: The FAS included all participants who entered the study treatment period.
CBR was defined as the percentage of participants with BOR of irCR or irPR or irdurable stable disease (irdSD) (duration of irSD \>=23 weeks) \[irCR + irPR + irdSD\] based on irRECIST v1.1. irCR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have reduction in their short axis to \<10 mm. irPR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference baseline sum of longest diameter. irSD: neither sufficient shrinkage to qualify for irPR nor sufficient increase to qualify for irPD, taking as reference smallest sum diameters while on study. irPD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Phase 1b: All Participants
n=124 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=145 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=21 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=21 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=22 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=20 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) Based on irRECIST Version 1.1
|
58.9 percentage of participants
Interval 49.7 to 67.6
|
80.0 percentage of participants
Interval 72.6 to 86.2
|
61.9 percentage of participants
Interval 38.4 to 81.9
|
57.1 percentage of participants
Interval 34.0 to 78.2
|
45.5 percentage of participants
Interval 24.4 to 67.8
|
40.0 percentage of participants
Interval 19.1 to 63.9
|
NA percentage of participants
Here, Number and 95% CI could not be estimated as insufficient number of participants were available for analysis in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose date until irPD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor (up to 73 months)Population: The FAS included all participants who entered the study treatment period. As planned, data for this outcome measure dSD rate (where SD\>=23 weeks) was not analyzed and collected separately but was included and analyzed in outcome measure CBR (irCR+irPR+\[irSD duration \>=23 weeks\]).
Durable SD rate is defined as the percentage of participants whose observed BOR is irSD and the duration of irSD is \>=23 weeks based on irRECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First documentation of irCR or irPR until first documentation of progression or death (up to 73 months)Population: The FAS included all participants who entered the study treatment period. Here "overall number of participants analyzed, N" signifies participants who had irCR or irPR. Here, "N" for Phase1b and 2, Lenvatinib 20 mg/day + Pembrolizumab 200 mg: Leiomyosarcoma was zero as there were no events of irCR or irPR in this arm.
DOR: time from date of first observation of response (irPR or irCR) to date of the first observation of progression based on irRECIST 1.1, or date of death, whatever the cause. irCR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have reduction in their short axis \<10 mm. irPR: at least 30% decrease in sum of diameter (SOD) of target lesions, taking as reference baseline sum diameters. irPD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in SOD of target lesions, taking as reference smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Phase 1b: All Participants
n=50 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=92 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=10 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=5 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=9 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=5 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Objective Response (DOR) Based on irRECIST Version 1.1
|
NA months
Interval 8.5 to
Median and Upper limit of 95% CI could not be estimated because high number of participants in this arm were censored from the analyses.
|
16.6 months
Interval 9.7 to 18.4
|
12.5 months
Interval 2.7 to 28.6
|
14.5 months
Interval 2.4 to
Here, Upper limit of 95% CI could not be estimated as insufficient number of participants were available for analysis in this arm.
|
7.1 months
Interval 2.2 to 16.8
|
41.0 months
Interval 4.6 to
Here, Upper limit of 95% CI could not be estimated as insufficient number of participants were available for analysis in this arm.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post dose; Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours post dose, Cycle 2 Day 1: predose, 2-12 hour postdose and Cycles 3,4,5,6 Day 1 predose (Cycle length =21 days)Population: The Pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of lenvatinib and had evaluable concentration data. Here number analyzed "n" signifies number of participants who were evaluable for given time points.
Observed plasma concentration of Lenvatinib was reported here quantified by liquid chromatography with tandem mass spectrometry (LCMS/MS) method.
Outcome measures
| Measure |
Phase 1b: All Participants
n=2 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=1 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 1 Day 1: 0.5-4 hour
|
102.5 microgram per liter (mcg/L)
Standard Deviation 136.44
|
198.0 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 1 Day 1: 6-10 hour
|
210.5 microgram per liter (mcg/L)
Standard Deviation 65.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 1 Day 15: Predose
|
53.9 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
1.8 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 1 Day 15: 0.5-4 hour
|
78.4 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
2.6 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 1 Day 15: 6-10 hour
|
366.0 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
424.0 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 2 Day 1: Predose
|
35.4 microgram per liter (mcg/L)
Standard Deviation 13.08
|
364.0 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 2 Day 1: 2-12 hour
|
491.0 microgram per liter (mcg/L)
Standard Deviation 247.49
|
374.0 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 3 Day 1: Predose
|
23.3 microgram per liter (mcg/L)
Standard Deviation 31.92
|
118.0 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 4 Day 1: Predose
|
28.0 microgram per liter (mcg/L)
Standard Deviation 13.93
|
176.0 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 5 Day 1: Predose
|
19.9 microgram per liter (mcg/L)
Standard Deviation 14.91
|
2.5 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Plasma Concentrations of Lenvatinib
Cycle 6 Day 1: Predose
|
44.4 microgram per liter (mcg/L)
Standard Deviation 42.64
|
210.0 microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post dose; Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours post dose, Cycle 2 Day 1: predose, 2-12 hour postdose and Cycles 3,4,5,6 Day 1 predose (Cycle length =21 days):Population: The PK analysis set included all participants who had received at least 1 dose of lenvatinib and had evaluable concentration data. Here, overall number of participants analyzed, N signifies participants who were evaluable for this outcome measure and number analyzed "n" signifies number participants who were evaluable for given time points.
Observed plasma concentration of Lenvatinib was reported here quantified by LCMS/MS method.
Outcome measures
| Measure |
Phase 1b: All Participants
n=122 Participants
All participants with selected solid tumors (RCC, EC, NSCLC and Melanoma) received lenvatinib 24 or 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=138 Participants
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: NSCLC
n=20 Participants
Participant with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: RCC
n=20 Participants
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: EC
n=22 Participants
Participant with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 20 mg/Day + Pembrolizumab 200 mg: Melanoma
n=20 Participants
Participant with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 Participants
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 1:0.5-4 hour
|
82.2 mcg/L
Standard Deviation 145.44
|
35.5 mcg/L
Standard Deviation 78.13
|
24.0 mcg/L
Standard Deviation 33.59
|
79.9 mcg/L
Standard Deviation 118.94
|
41.8 mcg/L
Standard Deviation 100.34
|
123.8 mcg/L
Standard Deviation 169.05
|
—
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 1:6-10 hour
|
231.7 mcg/L
Standard Deviation 109.67
|
190.8 mcg/L
Standard Deviation 96.25
|
154.3 mcg/L
Standard Deviation 69.56
|
224.1 mcg/L
Standard Deviation 109.95
|
169.7 mcg/L
Standard Deviation 95.78
|
214.2 mcg/L
Standard Deviation 86.51
|
116 mcg/L
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 15:Predose
|
66.6 mcg/L
Standard Deviation 36.56
|
67.2 mcg/L
Standard Deviation 80.70
|
52.1 mcg/L
Standard Deviation 61.70
|
62.9 mcg/L
Standard Deviation 87.36
|
60.9 mcg/L
Standard Deviation 46.38
|
61.1 mcg/L
Standard Deviation 69.54
|
52.2 mcg/L
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 15:0.5-4 hour
|
129.3 mcg/L
Standard Deviation 109.72
|
122.4 mcg/L
Standard Deviation 114.62
|
93.1 mcg/L
Standard Deviation 117.35
|
275.3 mcg/L
Standard Deviation 305.30
|
142.8 mcg/L
Standard Deviation 149.90
|
153.9 mcg/L
Standard Deviation 135.79
|
45.9 mcg/L
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 15:6-10 hour
|
271.3 mcg/L
Standard Deviation 103.60
|
206.3 mcg/L
Standard Deviation 97.29
|
241.8 mcg/L
Standard Deviation 241.52
|
266.8 mcg/L
Standard Deviation 146.41
|
210.6 mcg/L
Standard Deviation 78.37
|
249.7 mcg/L
Standard Deviation 91.65
|
161 mcg/L
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 2 Day 1:Predose
|
57.2 mcg/L
Standard Deviation 60.58
|
54.6 mcg/L
Standard Deviation 64.43
|
49.2 mcg/L
Standard Deviation 46.63
|
51.6 mcg/L
Standard Deviation 66.72
|
42.0 mcg/L
Standard Deviation 48.16
|
22.3 mcg/L
Standard Deviation 21.61
|
26.1 mcg/L
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 2 Day 1:2-12 hour
|
199.7 mcg/L
Standard Deviation 155.08
|
171.7 mcg/L
Standard Deviation 119.34
|
218.6 mcg/L
Standard Deviation 83.83
|
295.0 mcg/L
Standard Deviation 190.80
|
166.5 mcg/L
Standard Deviation 128.95
|
204.7 mcg/L
Standard Deviation 174.60
|
—
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 3 Day 1:Predose
|
53.2 mcg/L
Standard Deviation 59.53
|
59.0 mcg/L
Standard Deviation 67.58
|
62.8 mcg/L
Standard Deviation 65.77
|
99.4 mcg/L
Standard Deviation 132.33
|
43.7 mcg/L
Standard Deviation 50.45
|
37.9 mcg/L
Standard Deviation 29.19
|
—
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 4 Day 1:Predose
|
50.7 mcg/L
Standard Deviation 52.16
|
56.0 mcg/L
Standard Deviation 61.56
|
65.8 mcg/L
Standard Deviation 115.31
|
53.4 mcg/L
Standard Deviation 81.66
|
34.3 mcg/L
Standard Deviation 54.94
|
18.8 mcg/L
Standard Deviation 34.33
|
61.9 mcg/L
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 5 Day 1:Predose
|
53.5 mcg/L
Standard Deviation 56.69
|
52.1 mcg/L
Standard Deviation 65.15
|
60.8 mcg/L
Standard Deviation 58.38
|
71.8 mcg/L
Standard Deviation 134.39
|
37.7 mcg/L
Standard Deviation 42.97
|
39.0 mcg/L
Standard Deviation 29.50
|
—
|
—
|
—
|
|
Plasma Concentrations of Lenvatinib
Cycle 6 Day 1:Predose
|
40.6 mcg/L
Standard Deviation 33.66
|
51.8 mcg/L
Standard Deviation 49.19
|
114.0 mcg/L
Standard Deviation 189.97
|
49.9 mcg/L
Standard Deviation 68.97
|
36.9 mcg/L
Standard Deviation 34.12
|
34.2 mcg/L
Standard Deviation 31.86
|
—
|
—
|
—
|
Adverse Events
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
Serious events: 73 serious events
Other events: 122 other events
Deaths: 88 deaths
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
Serious events: 81 serious events
Other events: 145 other events
Deaths: 74 deaths
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
Serious events: 12 serious events
Other events: 21 other events
Deaths: 15 deaths
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
Serious events: 15 serious events
Other events: 21 other events
Deaths: 16 deaths
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
Serious events: 12 serious events
Other events: 22 other events
Deaths: 15 deaths
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
Serious events: 17 serious events
Other events: 20 other events
Deaths: 16 deaths
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
n=2 participants at risk
Participants with RCC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=1 participants at risk
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
n=124 participants at risk
Participants with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
n=145 participants at risk
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
n=21 participants at risk
Participants with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
n=21 participants at risk
Participants with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
n=22 participants at risk
Participants with HNSCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
n=20 participants at risk
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 participants at risk
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.1%
6/145 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridial sepsis
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ulcer perforation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Groin infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.1%
6/145 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hypobarism
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Troponin increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.1%
6/145 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy toxic
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.1%
6/145 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.2%
4/124 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.5%
8/124 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.4%
5/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
n=2 participants at risk
Participants with RCC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
n=1 participants at risk
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
n=124 participants at risk
Participants with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
n=145 participants at risk
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
n=21 participants at risk
Participants with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
n=21 participants at risk
Participants with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
n=22 participants at risk
Participants with HNSCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
n=20 participants at risk
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
n=1 participants at risk
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.1%
10/124 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.3%
12/145 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrioventricular block first degree
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular arrhythmia
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
49.2%
61/124 • Number of events 77 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
41.4%
60/145 • Number of events 66 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 10 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
38.1%
8/21 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
27.3%
6/22 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
40.0%
8/20 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
50.0%
1/2 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.1%
10/124 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
7/145 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
33.1%
41/124 • Number of events 50 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
29.7%
43/145 • Number of events 55 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
42.9%
9/21 • Number of events 14 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
22.7%
5/22 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
2/2 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
63.7%
79/124 • Number of events 270 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
66.9%
97/145 • Number of events 330 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
61.9%
13/21 • Number of events 23 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
57.1%
12/21 • Number of events 39 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
36.4%
8/22 • Number of events 26 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
55.0%
11/20 • Number of events 36 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.7%
12/124 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.5%
21/145 • Number of events 30 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
53.2%
66/124 • Number of events 144 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
51.0%
74/145 • Number of events 132 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
61.9%
13/21 • Number of events 24 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
47.6%
10/21 • Number of events 18 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
40.9%
9/22 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
60.0%
12/20 • Number of events 19 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
100.0%
2/2 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
36.3%
45/124 • Number of events 79 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
43.4%
63/145 • Number of events 109 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
31.8%
7/22 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
45.2%
56/124 • Number of events 137 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
30.3%
44/145 • Number of events 84 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
42.9%
9/21 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
38.1%
8/21 • Number of events 14 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
27.3%
6/22 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
50.0%
10/20 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
53.2%
66/124 • Number of events 159 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
65.5%
95/145 • Number of events 261 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
66.7%
14/21 • Number of events 21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
71.4%
15/21 • Number of events 33 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
50.0%
11/22 • Number of events 25 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
60.0%
12/20 • Number of events 21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
100.0%
2/2 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
29.8%
37/124 • Number of events 59 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 19 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
28.6%
6/21 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
45.0%
9/20 • Number of events 14 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
12.1%
15/124 • Number of events 28 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
12.4%
18/145 • Number of events 33 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Liver function test increased
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
36.3%
45/124 • Number of events 103 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
31.7%
46/145 • Number of events 79 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
22.7%
5/22 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
30.0%
6/20 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
2/2 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
54.8%
68/124 • Number of events 135 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
48.3%
70/145 • Number of events 114 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
47.6%
10/21 • Number of events 15 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
76.2%
16/21 • Number of events 30 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
45.5%
10/22 • Number of events 14 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
50.0%
10/20 • Number of events 18 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
28.2%
35/124 • Number of events 65 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.8%
20/145 • Number of events 44 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
12.1%
15/124 • Number of events 21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.5%
21/145 • Number of events 47 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 10 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
39.5%
49/124 • Number of events 99 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
48.3%
70/145 • Number of events 123 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
38.1%
8/21 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
35.0%
7/20 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.2%
25/124 • Number of events 38 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
24.8%
36/145 • Number of events 47 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
22.6%
28/124 • Number of events 39 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.8%
20/145 • Number of events 39 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.3%
19/124 • Number of events 24 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.7%
30/145 • Number of events 38 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
28.6%
6/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
33.9%
42/124 • Number of events 62 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
30.3%
44/145 • Number of events 65 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
27.3%
6/22 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
29.8%
37/124 • Number of events 121 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
46.2%
67/145 • Number of events 168 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
38.1%
8/21 • Number of events 23 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
22.7%
5/22 • Number of events 20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
65.0%
13/20 • Number of events 38 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
100.0%
2/2 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
29.8%
37/124 • Number of events 62 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
40.7%
59/145 • Number of events 78 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
47.6%
10/21 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
27.3%
6/22 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.3%
9/124 • Number of events 10 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.3%
28/145 • Number of events 41 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
50.0%
1/2 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
50.0%
1/2 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.2%
4/124 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
100.0%
2/2 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
60.5%
75/124 • Number of events 173 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
45.5%
66/145 • Number of events 175 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
42.9%
9/21 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
38.1%
8/21 • Number of events 25 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
36.4%
8/22 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
45.0%
9/20 • Number of events 15 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.9%
11/124 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.1%
19/145 • Number of events 31 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
30.0%
6/20 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.3%
9/124 • Number of events 17 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.6%
7/124 • Number of events 10 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.9%
10/145 • Number of events 10 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.6%
7/124 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.1%
6/145 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.0%
5/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
30.6%
38/124 • Number of events 58 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
25.5%
37/145 • Number of events 52 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.7%
12/124 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.7%
14/145 • Number of events 24 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.4%
5/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
17.7%
22/124 • Number of events 30 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.8%
20/145 • Number of events 23 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.9%
11/124 • Number of events 15 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.4%
5/145 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.0%
5/124 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.3%
15/145 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.5%
18/124 • Number of events 21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.2%
9/145 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.4%
5/145 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.3%
9/124 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.9%
11/124 • Number of events 15 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.6%
11/145 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
27.3%
6/22 • Number of events 22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.0%
13/145 • Number of events 17 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
17.7%
22/124 • Number of events 70 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.1%
6/145 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
11.3%
14/124 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.6%
11/145 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Cyst
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.5%
8/124 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.4%
5/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.4%
29/124 • Number of events 38 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
18.6%
27/145 • Number of events 37 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
30.0%
6/20 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.2%
4/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.3%
15/145 • Number of events 18 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.5%
13/124 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.5%
21/145 • Number of events 28 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
General disorders
Temperature intolerance
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.9%
10/145 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.0%
5/124 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.5%
8/124 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.2%
4/124 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
11.3%
14/124 • Number of events 17 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.2%
9/145 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
28.6%
6/21 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.0%
13/145 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.7%
17/124 • Number of events 37 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
12.4%
18/145 • Number of events 35 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.6%
7/124 • Number of events 20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.8%
20/145 • Number of events 67 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
11.3%
14/124 • Number of events 21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
11.7%
17/145 • Number of events 31 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.3%
9/124 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
7/145 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.2%
9/145 • Number of events 14 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.5%
13/124 • Number of events 26 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
29/145 • Number of events 71 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.3%
12/145 • Number of events 15 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.5%
8/124 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.1%
6/145 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
16.1%
20/124 • Number of events 44 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
22.1%
32/145 • Number of events 114 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 18 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.0%
5/124 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
7/145 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.7%
17/124 • Number of events 23 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.6%
11/145 • Number of events 17 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
50.0%
10/20 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.6%
11/145 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.5%
8/124 • Number of events 10 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.6%
11/145 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.3%
15/145 • Number of events 32 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
29/145 • Number of events 102 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.5%
8/124 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
35.0%
7/20 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.3%
19/124 • Number of events 33 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.9%
10/145 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.3%
12/145 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.0%
5/124 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.9%
10/145 • Number of events 17 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.5%
13/124 • Number of events 18 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
11.7%
17/145 • Number of events 24 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.5%
13/124 • Number of events 14 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.0%
13/145 • Number of events 15 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.2%
4/124 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
16.1%
20/124 • Number of events 26 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.8%
20/145 • Number of events 31 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
12.1%
15/124 • Number of events 20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.3%
28/145 • Number of events 49 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
11.3%
14/124 • Number of events 19 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.8%
20/145 • Number of events 24 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.9%
11/124 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.9%
10/145 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.2%
4/124 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.3%
9/124 • Number of events 10 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.6%
11/145 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.0%
5/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.3%
9/124 • Number of events 10 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.4%
5/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
11.3%
14/124 • Number of events 18 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
16.6%
24/145 • Number of events 29 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.6%
7/124 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.2%
4/124 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.3%
12/145 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.69%
1/145 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.2%
9/145 • Number of events 9 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.6%
11/145 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
6/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.1%
10/124 • Number of events 10 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
26.6%
33/124 • Number of events 44 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
46.2%
67/145 • Number of events 103 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
31.8%
7/22 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
30.0%
6/20 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
17.7%
22/124 • Number of events 26 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
29.7%
43/145 • Number of events 68 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
38.1%
8/21 • Number of events 17 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
40.0%
8/20 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.5%
13/124 • Number of events 21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.5%
21/145 • Number of events 32 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.3%
9/124 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
16.6%
24/145 • Number of events 31 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
31.8%
7/22 • Number of events 21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.6%
2/124 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
7/145 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 40 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.1%
3/145 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
18.6%
27/145 • Number of events 47 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.0%
13/145 • Number of events 15 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
6.9%
10/145 • Number of events 11 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.4%
3/124 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.9%
11/124 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
3.2%
4/124 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
7.6%
11/145 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
12.1%
15/124 • Number of events 16 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
17.9%
26/145 • Number of events 33 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.0%
5/124 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
5.5%
8/145 • Number of events 8 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
27.4%
34/124 • Number of events 80 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
31.7%
46/145 • Number of events 112 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 7 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
15.3%
19/124 • Number of events 22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.5%
21/145 • Number of events 28 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
28.6%
6/21 • Number of events 13 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 4 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
8.1%
10/124 • Number of events 22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
17.2%
25/145 • Number of events 37 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 12 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
2.8%
4/145 • Number of events 5 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
16.1%
20/124 • Number of events 36 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
17.2%
25/145 • Number of events 44 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 6 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.81%
1/124 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
1.4%
2/145 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/22 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/124 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/145 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/20 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
0.00%
0/1 • From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
The safety analysis set included all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place