Trial Outcomes & Findings for Derazantinib and Atezolizumab in Patients With Urothelial Cancer (NCT NCT04045613)
NCT ID: NCT04045613
Last Updated: 2023-10-13
Results Overview
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
95 participants
Primary outcome timeframe
From first dose up to 2 years
Results posted on
2023-10-13
Participant Flow
From August, 2019 to September, 2022, 321 patients underwent molecular screening, 131 underwent clinical screening, and 95 entered the study and were assigned treatment
Participant milestones
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg
Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion
Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose o f 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
14
|
12
|
2
|
8
|
10
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
14
|
12
|
2
|
8
|
10
|
17
|
Reasons for withdrawal
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg
Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion
Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose o f 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
3
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other reasons
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Progressive disease: Clinical progression
|
1
|
0
|
3
|
1
|
1
|
3
|
3
|
|
Overall Study
Progressive disease: Radiological progression
|
24
|
6
|
8
|
0
|
6
|
6
|
11
|
Baseline Characteristics
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=32 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily+ Atezolizumab 1200 mg
n=14 Participants
Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily+ Atezolizumab 1200 mg
n=12 Participants
Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=2 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
n=8 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=10 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=17 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 10.17 • n=99 Participants
|
65.6 years
STANDARD_DEVIATION 9.84 • n=107 Participants
|
53.3 years
STANDARD_DEVIATION 12.58 • n=206 Participants
|
67.5 years
STANDARD_DEVIATION 12.02 • n=7 Participants
|
66.6 years
STANDARD_DEVIATION 11.94 • n=31 Participants
|
62.7 years
STANDARD_DEVIATION 16.10 • n=30 Participants
|
64.2 years
STANDARD_DEVIATION 7.61 • n=3 Participants
|
64.6 years
STANDARD_DEVIATION 11.63 • n=6 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
38 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
57 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 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
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
58 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
24 Participants
n=6 Participants
|
|
Site of primary tumor at diagnosis
Bladder
|
19 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
49 Participants
n=6 Participants
|
|
Site of primary tumor at diagnosis
Renal pelvis
|
9 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
|
Site of primary tumor at diagnosis
Ureter
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
|
Site of primary tumor at diagnosis
Missing
|
1 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
|
1 Participants
n=6 Participants
|
|
Site of primary tumor at diagnosis
Other site of primary tumor
|
0 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Scale 0
|
14 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
31 Participants
n=6 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Scale 1
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
55 Participants
n=6 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Scale 2
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
|
Number of previous anti-cancer treatments
One treatment
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
|
Number of previous anti-cancer treatments
Two treatments
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
23 Participants
n=6 Participants
|
|
Number of previous anti-cancer treatments
Three or more treatments
|
18 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
51 Participants
n=6 Participants
|
|
Number of previous anti-cancer treatments
No treatment
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Prior immune checkpoint inhibitor treatment
|
26 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
61 Participants
n=6 Participants
|
|
Reason previous therapy ended
Treatment completed
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
|
Reason previous therapy ended
Progressive disease
|
23 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
71 Participants
n=6 Participants
|
|
Reason previous therapy ended
Toxicity
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Reason previous therapy ended
Other
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Reason previous therapy ended
Unknown
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Reason previous therapy ended
No previous therapy
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 2 yearsPopulation: Efficacy analyses were performed using the modified Intent-to-Treat (mITT) population: all patients who received at least one dose of derazantinib or atezolizumab, and had at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Outcome measures
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=32 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=2 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
n=7 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=10 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=17 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
0.0 Percentage of participants
Interval 0.0 to 84.2
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0.0 Percentage of participants
Interval 0.0 to 30.8
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose up to 2 yearsPopulation: The safety/intent-to-treat (ITT) population consisted of all patients who received at least one dose of derazantinib or atezolizumab
The RP2D was determined by a joint decision taken by the Independent Data Monitoring Committee (IDMC), Investigators, and the Sponsor in reviewing the aggregate of DLT and AE data, and considering efficacy data
Outcome measures
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=26 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)
|
300 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose up to 2 yearsPopulation: The maximum tolerated dose (MTD)-determining population included all patients enrolled in the MTD Part of each dose level who met the following minimum criteria during the DLT period: * received at least one dose of derazantinib and atezolizumab and has experienced a DLT; * received ≥ 90% of the derazantinib and atezolizumab dose, respectively, in Cycle 1 and did not experience a DLT, have been observed for ≥ 21 days following the first dose, and have been evaluated for safety
In Substudy 2, the primary endpoint was the number of patients with DLTs. A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to derazantinib or the combination of derazantinib and atezolizumab
Outcome measures
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=6 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=5 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose up to 2 yearsPopulation: Efficacy analyses were performed using the modified Intent-to-Treat (mITT) population: all patients who received at least one dose of derazantinib or atezolizumab, and had at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression
DCR was defined as the proportion of patients who achieved a confirmed clinical response (CR), partial response (PR) or stable disease (SD) by BICR using the internationally recognized criteria in accordance with RECIST Version 1.1
Outcome measures
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=32 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=11 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
n=12 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=2 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=7 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=10 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=17 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies
|
18.8 Percentage of participants
Interval 7.2 to 36.4
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
50.0 Percentage of participants
Interval 1.3 to 98.7
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
52.9 Percentage of participants
Interval 27.8 to 77.0
|
SECONDARY outcome
Timeframe: From first dose up to 2 yearsPopulation: Efficacy analyses were performed using the modified Intent-to-Treat (mITT) population: all patients who received at least one dose of derazantinib or atezolizumab, and had at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression
DOR was calculated from the first date of documented tumor response (confirmed CR or PR) to the date of disease progression as assessed by BICR or death per RECIST 1.1
Outcome measures
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=32 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=11 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
n=12 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=2 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=7 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=10 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=17 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) Per RECIST 1.1
|
6.9 months
Value(s) could not be evaluable due insufficient number of participants with events
|
NA months
Value(s) could not be evaluable due insufficient number of participants with events
|
7.4 months
Interval 6.9 to 7.9
|
NA months
Value(s) could not be evaluable due insufficient number of participants with events
|
3.3 months
Value(s) could not be evaluable due insufficient number of participants with events
|
NA months
Value(s) could not be evaluable due insufficient number of participants with events
|
NA months
Value(s) could not be evaluable due insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose up to 2 yearsPopulation: Efficacy analyses were performed using the modified Intent-to-Treat (mITT) population: all patients who received at least one dose of derazantinib or atezolizumab, and had at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression.
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Outcome measures
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=11 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=12 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
ORR Based on RECIST 1.1 (Substudy 2)
|
0.0 Percentage of participants
Interval 0.0 to 28.5
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose up to 2 yearsPopulation: Efficacy analyses were performed using the modified Intent-to-Treat (mITT) population: all patients who received at least one dose of derazantinib or atezolizumab, and had at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression
PFS was calculated as the time from cohort assignment until disease progression as assessed by BICR, or death from any cause, whichever came first
Outcome measures
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=32 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=11 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
n=12 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=2 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=7 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=10 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=17 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) by RECIST in All Substudies
|
2.0 months
Interval 1.9 to 2.1
|
2.0 months
Interval 1.5 to 2.1
|
4.2 months
Interval 0.7 to 10.8
|
2.5 months
Interval 0.6 to 4.4
|
2.0 months
Interval 0.6 to 4.7
|
1.9 months
Interval 0.2 to 4.1
|
2.1 months
Interval 2.1 to 7.0
|
SECONDARY outcome
Timeframe: From first dose up to 2 yearsPopulation: Efficacy analyses were performed using the modified Intent-to-Treat (mITT) population: all patients who received at least one dose of derazantinib or atezolizumab, and had at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression
OS was calculated from the date of cohort assignment until death from any cause
Outcome measures
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=32 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=11 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
n=12 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=2 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=7 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=10 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=17 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in All Substudies
|
4.7 months
Interval 3.4 to 7.3
|
8.7 months
Interval 3.0 to
Value(s) could not be evaluable due insufficient number of participants with events
|
12.6 months
Interval 2.5 to
Value(s) could not be evaluable due insufficient number of participants with events
|
4.2 months
Interval 2.3 to 6.2
|
NA months
Interval 2.3 to
Value(s) could not be evaluable due insufficient number of participants with events
|
6.2 months
Interval 1.1 to 11.8
|
7.5 months
Interval 5.6 to 9.0
|
SECONDARY outcome
Timeframe: From first dose and until 90 days following the last dosePopulation: The safety/intent-to-treat (ITT) population consisted of all patients who received at least one dose of derazantinib or atezolizumab
Common Terminology Criteria for Adverse Events (CTCAE) displayed by increasing severity grades 3 to 5 (CTCAE grade 3/4/5 )
Outcome measures
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=32 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=14 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
n=12 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=2 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=8 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=10 Participants
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=17 Participants
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With at Least Grade 3 Adverse Events (AEs)
Number of patients with only unrelated CTCAE Grade ≥3
|
11 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Number of Patients With at Least Grade 3 Adverse Events (AEs)
Number of patients with related CTCAE Grade ≥3
|
11 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
9 Participants
|
|
Number of Patients With at Least Grade 3 Adverse Events (AEs)
Number of patients without CTCAE Grade ≥3
|
10 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
Adverse Events
Substudy 1: Derazantinib 300 mg Once Daily
Serious events: 17 serious events
Other events: 30 other events
Deaths: 8 deaths
Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg
Serious events: 4 serious events
Other events: 14 other events
Deaths: 3 deaths
Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Serious events: 6 serious events
Other events: 12 other events
Deaths: 3 deaths
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
Serious events: 6 serious events
Other events: 10 other events
Deaths: 4 deaths
Substudy 5: Derazantinib 200 mg Twice Daily
Serious events: 8 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=32 participants at risk
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg
n=14 participants at risk
Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=12 participants at risk
Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=2 participants at risk
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
n=8 participants at risk
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=10 participants at risk
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=17 participants at risk
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Blood creatine phosphokinase increased
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Blood creatinine increased
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Intestinal perforation
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Renal and urinary disorders
Haematuria
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Endocarditis
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Infection
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Sepsis
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Injury, poisoning and procedural complications
Fracture
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Vascular disorders
Embolism
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Disease progression
|
21.9%
7/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
3/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
40.0%
4/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Fatigue
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Hypothermia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Pain
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
Other adverse events
| Measure |
Substudy 1: Derazantinib 300 mg Once Daily
n=32 participants at risk
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg
n=14 participants at risk
Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=12 participants at risk
Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg
n=2 participants at risk
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily
n=8 participants at risk
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
|
Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg
n=10 participants at risk
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
|
Substudy 5: Derazantinib 200 mg Twice Daily
n=17 participants at risk
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
|
|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
31.2%
10/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
41.7%
5/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
2/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
29.4%
5/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Amylase increased
|
12.5%
4/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
12/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
3/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
2/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
23.5%
4/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
4/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Blood creatine phosphokinase increased
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Blood creatinine increased
|
18.8%
6/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
17.6%
3/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
4/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Blood phosphorus increased
|
12.5%
4/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
33.3%
4/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
C-reactive protein increased
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Electrocardiogram QT prolonged
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
4/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Haemoglobin decreased
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Lipase increased
|
12.5%
4/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Platelet count decreased
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Transaminases increased
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Investigations
Weight decreased
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Cardiac disorders
Palpitations
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Blood and lymphatic system disorders
Anaemia
|
21.9%
7/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
30.0%
3/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Nervous system disorders
Dysgeusia
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Nervous system disorders
Sciatica
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Nervous system disorders
Tremor
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Cataract
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Central serous chorioretinopathy
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Dry eye
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Keratitis
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Maculopathy
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Punctate keratitis
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Vision blurred
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Eye disorders
Xerophthalmia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Constipation
|
31.2%
10/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
37.5%
3/8 • AEs were assessed from first dose and until 90 days following the last dose
|
30.0%
3/10 • AEs were assessed from first dose and until 90 days following the last dose
|
17.6%
3/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
21.9%
7/32 • AEs were assessed from first dose and until 90 days following the last dose
|
28.6%
4/14 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
3/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
2/8 • AEs were assessed from first dose and until 90 days following the last dose
|
40.0%
4/10 • AEs were assessed from first dose and until 90 days following the last dose
|
29.4%
5/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Dry mouth
|
21.9%
7/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Nausea
|
43.8%
14/32 • AEs were assessed from first dose and until 90 days following the last dose
|
42.9%
6/14 • AEs were assessed from first dose and until 90 days following the last dose
|
33.3%
4/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
30.0%
3/10 • AEs were assessed from first dose and until 90 days following the last dose
|
29.4%
5/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Stomatitis
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
6/32 • AEs were assessed from first dose and until 90 days following the last dose
|
28.6%
4/14 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
3/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
30.0%
3/10 • AEs were assessed from first dose and until 90 days following the last dose
|
23.5%
4/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Renal and urinary disorders
Dysuria
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Renal and urinary disorders
Haematuria
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Renal and urinary disorders
Pollakiuria
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
11.8%
2/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
4/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
17.6%
3/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.1%
9/32 • AEs were assessed from first dose and until 90 days following the last dose
|
21.4%
3/14 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
3/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
35.3%
6/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
28.6%
4/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
2/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
2/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
4/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
37.5%
3/8 • AEs were assessed from first dose and until 90 days following the last dose
|
20.0%
2/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
5.9%
1/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Oral candidiasis
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Infections and infestations
Urinary tract infection
|
9.4%
3/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
17.6%
3/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Vascular disorders
Hypertension
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
7.1%
1/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
17.6%
3/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Vascular disorders
Lymphoedema
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Asthenia
|
25.0%
8/32 • AEs were assessed from first dose and until 90 days following the last dose
|
14.3%
2/14 • AEs were assessed from first dose and until 90 days following the last dose
|
41.7%
5/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
37.5%
3/8 • AEs were assessed from first dose and until 90 days following the last dose
|
30.0%
3/10 • AEs were assessed from first dose and until 90 days following the last dose
|
29.4%
5/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Fatigue
|
25.0%
8/32 • AEs were assessed from first dose and until 90 days following the last dose
|
35.7%
5/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
30.0%
3/10 • AEs were assessed from first dose and until 90 days following the last dose
|
35.3%
6/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Mucosal inflammation
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Oedema
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Oedema peripheral
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Pain
|
6.2%
2/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
16.7%
2/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
General disorders
Pyrexia
|
3.1%
1/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
25.0%
3/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/12 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/2 • AEs were assessed from first dose and until 90 days following the last dose
|
12.5%
1/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/32 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/14 • AEs were assessed from first dose and until 90 days following the last dose
|
8.3%
1/12 • AEs were assessed from first dose and until 90 days following the last dose
|
50.0%
1/2 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/8 • AEs were assessed from first dose and until 90 days following the last dose
|
10.0%
1/10 • AEs were assessed from first dose and until 90 days following the last dose
|
0.00%
0/17 • AEs were assessed from first dose and until 90 days following the last dose
|
Additional Information
Study Director
Basilea Pharmaceutica International Ltd, Allschwil
Phone: +41 76 302 53 10
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60