Trial Outcomes & Findings for Trial of MSC1936369B in Subjects With Solid Tumors (NCT NCT00982865)
NCT ID: NCT00982865
Last Updated: 2018-10-23
Results Overview
DLT was defined as any of following toxicities at any dose level according to using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) v3.0(CTCAE), probably or possibly related to trial medication by investigator or sponsor: a)Any Grade 3 or more non-haematological toxicity excluding: (i)Grade 3 asymptomatic increase in liver function tests (Aspartate Aminotransferase, Alanine transaminase, Alkaline Phosphatase reversible within 7 days for subjects without liver involvement, or grade 4 for subjects with liver involvement; (ii)Grade 3 vomiting if it is encountered despite adequate and optimal therapy (e.g. serotonin \[5HT3\] antagonists and corticosteroids); (iii)Grade 3 diarrhoea if it is encountered despite adequate and optimal anti diarrhoea therapy; b)Grade 4 neutropenia of \>5 days duration or febrile neutropenia lasting for more than 1 day; c)Grade 4 thrombocytopenia \>1 day or grade 3 with bleeding; d)Any treatment delay \>2 weeks due to drug-related AEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
182 participants
Primary outcome timeframe
Day 1 up to Day 21 of Cycle 1
Results posted on
2018-10-23
Participant Flow
First/last subject (informed consent): December 2007/March 2012. Last subject completed: April 2016.
A total of 182 subjects entered the trial, of which 2 did not receive any treatment. 180 subjects received the study treatment and were included in the subject disposition table.
Participant milestones
| Measure |
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily (BID)
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
82
|
15
|
34
|
|
Overall Study
COMPLETED
|
49
|
82
|
15
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of MSC1936369B in Subjects With Solid Tumors
Baseline characteristics by cohort
| Measure |
MSC1936369B Regimen 1
n=49 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=82 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=15 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=34 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
>= 18 - <45 Years
|
4 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Age, Customized
>=45 - <65 Years
|
30 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
101 Participants
n=36 Participants
|
|
Age, Customized
>=65 Years
|
15 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
54 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
70 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
110 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 21 of Cycle 1Population: Dose Escalation Analysis Set included all subjects who meet at least 1 of following criteria: subjects who experienced any DLT during Cycle 1 \& who received planned treatment.
DLT was defined as any of following toxicities at any dose level according to using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) v3.0(CTCAE), probably or possibly related to trial medication by investigator or sponsor: a)Any Grade 3 or more non-haematological toxicity excluding: (i)Grade 3 asymptomatic increase in liver function tests (Aspartate Aminotransferase, Alanine transaminase, Alkaline Phosphatase reversible within 7 days for subjects without liver involvement, or grade 4 for subjects with liver involvement; (ii)Grade 3 vomiting if it is encountered despite adequate and optimal therapy (e.g. serotonin \[5HT3\] antagonists and corticosteroids); (iii)Grade 3 diarrhoea if it is encountered despite adequate and optimal anti diarrhoea therapy; b)Grade 4 neutropenia of \>5 days duration or febrile neutropenia lasting for more than 1 day; c)Grade 4 thrombocytopenia \>1 day or grade 3 with bleeding; d)Any treatment delay \>2 weeks due to drug-related AEs.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=44 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=74 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=15 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=33 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21
|
2 Subjects
|
6 Subjects
|
0 Subjects
|
6 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 253 weeksPopulation: Safety Analysis Set (SAF) included all subjects who received at least 1 dose of MSC1936369B treatment.
AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 253 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=49 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=82 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=15 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=34 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation
TEAEs
|
47 Subjects
|
82 Subjects
|
15 Subjects
|
34 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation
Serious TEAEs
|
23 Subjects
|
45 Subjects
|
8 Subjects
|
21 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation
TEAEs leading to discontinuation
|
13 Subjects
|
22 Subjects
|
2 Subjects
|
6 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 253 weeksPopulation: ALL subject analysis set was used which included all the subjects who signed the informed consent form and entered the study.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=49 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=83 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=15 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=35 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Death
|
10 Subjects
|
14 Subjects
|
2 Subjects
|
2 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 253 weeksPopulation: SAF analysis was used.
Any clinically significant changes in laboratory evaluations and vital signs were recorded as treatment emergent adverse events. The clinical laboratory parameters that were assessed included: Hematological parameters, Blood chemistry parameters, Urinalysis and the vital signs that were assessed included: Blood pressure, Heart rate, Temperature and Weight. SAF analysis was used.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=49 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=82 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=15 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=34 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Haemoglobin decreased
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Anaemia
|
10 Subjects
|
23 Subjects
|
3 Subjects
|
3 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Lymphopenia
|
3 Subjects
|
7 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Thrombocytopenia
|
3 Subjects
|
6 Subjects
|
2 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Platelet count decreased
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Neutropenia
|
0 Subjects
|
4 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Leukopenia
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Pancytopenia
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hyponatraemia
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hypokalaemia
|
4 Subjects
|
10 Subjects
|
2 Subjects
|
2 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hyperkalaemia
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hypocalcaemia
|
2 Subjects
|
7 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hypercalcaemia
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hypomagnesaemia
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hypophosphataemia
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hepatic enzyme increased
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hepatic function abnormal
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Alanine aminotransferase increased
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Aspartate aminotransferase increased
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Blood alkaline phosphatase increased
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hyperbilirubinaemia
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Blood lactate dehydrogenase increased
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Blood creatine phosphokinase increased
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
5 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Blood creatinine increased
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Blood 25-hydroxycholecalciferol decreased
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Vitamin D decreased
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Blood parathyroid hormone increased
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hyperglycaemia
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
C-reactive protein increased
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Proteinuria
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hyperthyroidism
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hypoalbuminaemia
|
3 Subjects
|
4 Subjects
|
0 Subjects
|
2 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Weight increased
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
3 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Weight decreased
|
6 Subjects
|
8 Subjects
|
4 Subjects
|
2 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hyperthermia
|
1 Subjects
|
5 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hypertension
|
7 Subjects
|
5 Subjects
|
1 Subjects
|
4 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Hypotension
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Heart rate increased
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Tachycardia
|
3 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Blood potassium increased
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours (h) post-dose on Cycle 1(C1) Day 1 (D1), Cycle 1 Day 12 (D12) and Cycle 3 (C3) Day 1Population: PK analysis set: subjects received at least 1 dose of drug \& provided sufficient PK serum samples for at least 1st 24h following 1st dose of C1D1. Number of Participants Analyzed=subjects evaluable for this endpoint \& Number analyzed=subjects evaluated at specified time point \& "0"indicates no subject analyzed for that specific time point.
Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=4 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=3 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=3 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=6 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=4 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=13 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 1
C1D1
|
2.02 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41.0
|
3.20 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 45.5
|
4.21 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.9
|
6.69 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.9
|
12.60 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15.4
|
62.32 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33.6
|
126.21 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 70.2
|
212.96 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 106.3
|
357.39 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30.7
|
325.99 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31.8
|
428.85 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 57.9
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 1
C1D12
|
2.92 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39.0
|
2.69 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 10.1
|
6.29 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.6
|
9.75 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63.3
|
21.93 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 110.5
|
54.47 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 116.2
|
150.67 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 78.1
|
175.94 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.5
|
413.58 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 9.1
|
602.12 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 11.0
|
425.26 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 71.0
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 1
C3D1
|
2.00 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2.90 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
5.60 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
8.06 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30.3
|
10.90 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 68.5
|
51.30 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
84.70 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 78.8
|
167.75 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15.5
|
—
|
282.44 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 14.9
|
652.70 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=3 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=5 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=3 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=3 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=4 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
n=14 Participants
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
n=12 Participants
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
n=5 Participants
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D15
|
2.28 ng/mL
Geometric Coefficient of Variation 58.0
|
7.77 ng/mL
Geometric Coefficient of Variation 96.2
|
4.21 ng/mL
Geometric Coefficient of Variation 39.9
|
18.78 ng/mL
Geometric Coefficient of Variation 32.2
|
18.47 ng/mL
Geometric Coefficient of Variation 33.1
|
34.87 ng/mL
Geometric Coefficient of Variation 36.8
|
131.71 ng/mL
Geometric Coefficient of Variation 14.7
|
286.88 ng/mL
Geometric Coefficient of Variation 21.8
|
539.17 ng/mL
Geometric Coefficient of Variation 37.1
|
432.46 ng/mL
Geometric Coefficient of Variation 7.6
|
492.81 ng/mL
Geometric Coefficient of Variation 117.1
|
450.29 ng/mL
Geometric Coefficient of Variation 67.4
|
629.85 ng/mL
Geometric Coefficient of Variation 71.3
|
1535.60 ng/mL
Geometric Coefficient of Variation 57.1
|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D1
|
1.65 ng/mL
Geometric Coefficient of Variation 59.2
|
2.87 ng/mL
Geometric Coefficient of Variation 56.6
|
4.55 ng/mL
Geometric Coefficient of Variation 113.4
|
17.26 ng/mL
Geometric Coefficient of Variation 27.8
|
30.90 ng/mL
Geometric Coefficient of Variation 32.6
|
39.19 ng/mL
Geometric Coefficient of Variation 69.7
|
187.98 ng/mL
Geometric Coefficient of Variation 39.7
|
321.85 ng/mL
Geometric Coefficient of Variation 32.7
|
306.63 ng/mL
Geometric Coefficient of Variation 110.4
|
373.59 ng/mL
Geometric Coefficient of Variation 24.9
|
605.11 ng/mL
Geometric Coefficient of Variation 48.8
|
539.02 ng/mL
Geometric Coefficient of Variation 78.0
|
680.87 ng/mL
Geometric Coefficient of Variation 45.6
|
990.92 ng/mL
Geometric Coefficient of Variation 64.9
|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (Without Food Effect)
C3D1
|
1.25 ng/mL
Geometric Coefficient of Variation 5.7
|
4.30 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
6.56 ng/mL
Geometric Coefficient of Variation 39.8
|
14.81 ng/mL
Geometric Coefficient of Variation 50.1
|
16.10 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
96.60 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
710.94 ng/mL
Geometric Coefficient of Variation 57.4
|
532.80 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
568.49 ng/mL
Geometric Coefficient of Variation 76.2
|
795.86 ng/mL
Geometric Coefficient of Variation 50.0
|
773.14 ng/mL
Geometric Coefficient of Variation 51.0
|
2344.91 ng/mL
Geometric Coefficient of Variation 23.1
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2Population: The food effect analysis set included all subjects who fulfilled following conditions: Food \& drink intake, trial medication administration according to protocol, \& not excreted irregularly, PK samples collected. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this endpoint.
Cmax was obtained directly from the concentration versus time curve. Summarized data over Day 1 and Day 2 was reported.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=8 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (With Food Effect)
Fasted
|
321.14 ng/mL
Geometric Coefficient of Variation 58.3
|
1158.00 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (With Food Effect)
Fed
|
305.94 ng/mL
Geometric Coefficient of Variation 45.6
|
370.70 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies the subjects who were evaluated at that specified time point.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=12 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Once Daily
C1D1
|
241.27 ng/mL
Geometric Coefficient of Variation 47.0
|
402.77 ng/mL
Geometric Coefficient of Variation 59.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Once Daily
C1D15
|
316.08 ng/mL
Geometric Coefficient of Variation 34.9
|
324.80 ng/mL
Geometric Coefficient of Variation 65.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Once Daily
C3D1
|
473.27 ng/mL
Geometric Coefficient of Variation 38.7
|
376.62 ng/mL
Geometric Coefficient of Variation 45.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1Population: PKS analysis set. Here "Number analyzed" signifies those who were evaluated at the specified time point.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=18 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=13 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Twice Daily
C1D1
|
132.57 ng/mL
Geometric Coefficient of Variation 40.2
|
206.46 ng/mL
Geometric Coefficient of Variation 41.7
|
263.08 ng/mL
Geometric Coefficient of Variation 68.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Twice Daily
C1D15
|
178.09 ng/mL
Geometric Coefficient of Variation 95.0
|
231.12 ng/mL
Geometric Coefficient of Variation 44.0
|
190.42 ng/mL
Geometric Coefficient of Variation 57.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Twice Daily
C3D1
|
139.60 ng/mL
Geometric Coefficient of Variation 26.6
|
157.46 ng/mL
Geometric Coefficient of Variation 53.7
|
329.28 ng/mL
Geometric Coefficient of Variation 73.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=4 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=3 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=3 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=6 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=4 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=13 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 1
C1D1
|
1.500 Hours (h)
Interval 1.02 to 1.53
|
0.750 Hours (h)
Interval 0.5 to 4.25
|
1.500 Hours (h)
Interval 1.0 to 2.5
|
1.500 Hours (h)
Interval 1.0 to 2.17
|
1.500 Hours (h)
Interval 1.0 to 2.5
|
1.000 Hours (h)
Interval 0.5 to 2.0
|
1.500 Hours (h)
Interval 1.0 to 4.0
|
1.017 Hours (h)
Interval 1.0 to 2.5
|
1.000 Hours (h)
Interval 0.98 to 1.5
|
1.483 Hours (h)
Interval 0.52 to 2.17
|
1.017 Hours (h)
Interval 0.5 to 6.0
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 1
C1D12
|
1.633 Hours (h)
Interval 0.5 to 2.5
|
0.533 Hours (h)
Interval 0.33 to 2.0
|
1.000 Hours (h)
Interval 1.0 to 2.5
|
1.000 Hours (h)
Interval 1.0 to 1.08
|
1.017 Hours (h)
Interval 1.0 to 1.05
|
1.500 Hours (h)
Interval 1.5 to 1.5
|
1.000 Hours (h)
Interval 0.5 to 3.92
|
2.000 Hours (h)
Interval 0.75 to 2.52
|
1.000 Hours (h)
Interval 0.5 to 4.0
|
1.500 Hours (h)
Interval 1.5 to 2.0
|
1.083 Hours (h)
Interval 0.52 to 8.0
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 1
C3D1
|
1.52 Hours (h)
Interval 1.52 to 1.52
|
0.500 Hours (h)
Interval 0.5 to 0.5
|
1.52 Hours (h)
Interval 1.52 to 1.52
|
1.000 Hours (h)
Interval 0.5 to 2.67
|
1.517 Hours (h)
Interval 1.0 to 4.05
|
1.500 Hours (h)
Interval 1.5 to 1.5
|
1.000 Hours (h)
Interval 1.0 to 3.58
|
1.508 Hours (h)
Interval 0.5 to 2.52
|
—
|
1.767 Hours (h)
Interval 1.5 to 2.03
|
2.000 Hours (h)
Interval 0.5 to 4.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=3 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=5 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=3 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=3 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=4 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
n=14 Participants
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
n=12 Participants
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
n=5 Participants
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D1
|
1.500 Hours (h)
Interval 1.5 to 1.92
|
1.017 Hours (h)
Interval 0.5 to 2.5
|
1.500 Hours (h)
Interval 1.0 to 2.0
|
1.000 Hours (h)
Interval 0.5 to 24.98
|
0.533 Hours (h)
Interval 0.52 to 2.0
|
1.500 Hours (h)
Interval 0.5 to 4.0
|
1.000 Hours (h)
Interval 0.58 to 2.02
|
0.500 Hours (h)
Interval 0.5 to 1.02
|
1.000 Hours (h)
Interval 0.47 to 1.5
|
1.500 Hours (h)
Interval 0.5 to 1.58
|
1.250 Hours (h)
Interval 0.33 to 2.02
|
1.500 Hours (h)
Interval 0.58 to 4.0
|
1.250 Hours (h)
Interval 0.5 to 2.5
|
2.000 Hours (h)
Interval 0.5 to 2.5
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D15
|
1.500 Hours (h)
Interval 1.42 to 2.0
|
0.967 Hours (h)
Interval 0.52 to 1.5
|
2.000 Hours (h)
Interval 0.43 to 2.0
|
0.667 Hours (h)
Interval 0.5 to 2.5
|
1.008 Hours (h)
Interval 1.0 to 1.02
|
1.500 Hours (h)
Interval 1.5 to 4.0
|
1.017 Hours (h)
Interval 0.5 to 2.12
|
1.500 Hours (h)
Interval 0.67 to 1.52
|
1.250 Hours (h)
Interval 1.0 to 1.5
|
1.500 Hours (h)
Interval 1.5 to 2.02
|
2.000 Hours (h)
Interval 1.0 to 2.08
|
1.517 Hours (h)
Interval 1.0 to 7.92
|
1.250 Hours (h)
Interval 0.5 to 3.0
|
1.458 Hours (h)
Interval 1.0 to 2.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (Without Food Effect)
C3D1
|
1.250 Hours (h)
Interval 1.0 to 1.5
|
2.000 Hours (h)
Interval 2.0 to 2.0
|
1.258 Hours (h)
Interval 1.0 to 1.52
|
1.000 Hours (h)
Interval 1.0 to 1.0
|
2.500 Hours (h)
Interval 2.5 to 2.5
|
—
|
1.50 Hours (h)
Interval 1.5 to 1.5
|
—
|
0.500 Hours (h)
Interval 0.5 to 0.5
|
2.000 Hours (h)
Interval 2.0 to 2.0
|
1.042 Hours (h)
Interval 0.58 to 1.5
|
1.333 Hours (h)
Interval 1.0 to 2.1
|
1.000 Hours (h)
Interval 0.5 to 2.02
|
1.000 Hours (h)
Interval 1.0 to 1.67
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2Population: The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. Summarized data over Day 1 and Day 2 was reported.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=8 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (With Food Effect)
Fasted
|
1.600 Hours (h)
Interval 0.33 to 2.5
|
1.000 Hours (h)
Interval 1.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (With Food Effect)
Fed
|
2.033 Hours (h)
Interval 1.5 to 4.0
|
6.000 Hours (h)
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=12 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Once Daily
C1D1
|
1.033 Hours (h)
Interval 1.0 to 1.5
|
1.500 Hours (h)
Interval 0.5 to 2.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Once Daily
C1D15
|
2.500 Hours (h)
Interval 1.52 to 2.5
|
1.492 Hours (h)
Interval 0.5 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Once Daily
C3D1
|
2.000 Hours (h)
Interval 1.5 to 2.5
|
1.000 Hours (h)
Interval 0.57 to 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=18 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=13 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Twice Daily
C1D1
|
1.500 Hours (h)
Interval 1.0 to 2.0
|
1.000 Hours (h)
Interval 0.5 to 4.0
|
0.667 Hours (h)
Interval 0.47 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Twice Daily
C1D15
|
1.500 Hours (h)
Interval 1.03 to 2.0
|
1.500 Hours (h)
Interval 0.5 to 2.55
|
1.500 Hours (h)
Interval 0.97 to 4.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Twice Daily
C3D1
|
1.467 Hours (h)
Interval 0.92 to 2.02
|
1.183 Hours (h)
Interval 0.5 to 2.07
|
1.467 Hours (h)
Interval 0.5 to 1.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=4 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=3 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=3 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=6 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=4 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=13 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 1
C1D1
|
4.6 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 431.3
|
5.2 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 63.9
|
18.5 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 49.8
|
22.7 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 29.2
|
52.7 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 74.5
|
213.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 84.0
|
531.3 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 55.4
|
889.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 31.9
|
1624.8 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 36.1
|
1748.1 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 38.8
|
2292.4 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 52.5
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 1
C1D12
|
7.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 269.8
|
6.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 89.3
|
26.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 55.0
|
35.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 79.7
|
83.6 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 67.7
|
182.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 125.1
|
691.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 51.4
|
880.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 45.7
|
1900.3 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 99.7
|
1991.4 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 19.2
|
1682.4 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 52.4
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 1
C3D1
|
6.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2.7 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
21.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
23.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 38.2
|
45.2 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 51.8
|
113.2 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
334.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 47.8
|
666.3 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 52.3
|
—
|
876.7 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 20.4
|
2064.1 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 55.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number Analyzed=0 because there was no subject analyzed at specified time point.
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=3 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=5 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=3 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=3 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=4 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
n=14 Participants
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
n=12 Participants
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
n=5 Participants
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: : Regimen 2 (Without Food Effect)
C1D1
|
1.9 hour*ng/mL
Geometric Coefficient of Variation 331.6
|
8.2 hour*ng/mL
Geometric Coefficient of Variation 53.1
|
6.7 hour*ng/mL
Geometric Coefficient of Variation 292.9
|
67.9 hour*ng/mL
Geometric Coefficient of Variation 93.9
|
74.4 hour*ng/mL
Geometric Coefficient of Variation 19.4
|
188.4 hour*ng/mL
Geometric Coefficient of Variation 61.7
|
625.7 hour*ng/mL
Geometric Coefficient of Variation 20.6
|
808.0 hour*ng/mL
Geometric Coefficient of Variation 15.7
|
861.1 hour*ng/mL
Geometric Coefficient of Variation 112.4
|
1484.6 hour*ng/mL
Geometric Coefficient of Variation 13.0
|
2287.0 hour*ng/mL
Geometric Coefficient of Variation 96.6
|
2216.5 hour*ng/mL
Geometric Coefficient of Variation 75.7
|
3415.6 hour*ng/mL
Geometric Coefficient of Variation 44.5
|
4041.3 hour*ng/mL
Geometric Coefficient of Variation 60.8
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: : Regimen 2 (Without Food Effect)
C1D15
|
4.3 hour*ng/mL
Geometric Coefficient of Variation 228.5
|
22.2 hour*ng/mL
Geometric Coefficient of Variation 42.1
|
13.8 hour*ng/mL
Geometric Coefficient of Variation 66.9
|
79.3 hour*ng/mL
Geometric Coefficient of Variation 57.9
|
67.8 hour*ng/mL
Geometric Coefficient of Variation 53.9
|
161.5 hour*ng/mL
Geometric Coefficient of Variation 14.1
|
621.2 hour*ng/mL
Geometric Coefficient of Variation 12.7
|
906.3 hour*ng/mL
Geometric Coefficient of Variation 15.4
|
1553.9 hour*ng/mL
Geometric Coefficient of Variation 122.5
|
1826.2 hour*ng/mL
Geometric Coefficient of Variation 17.9
|
1862.3 hour*ng/mL
Geometric Coefficient of Variation 96.4
|
2086.6 hour*ng/mL
Geometric Coefficient of Variation 69.9
|
3436.8 hour*ng/mL
Geometric Coefficient of Variation 64.7
|
5765.9 hour*ng/mL
Geometric Coefficient of Variation 15.3
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: : Regimen 2 (Without Food Effect)
C3D1
|
0.5 hour*ng/mL
Geometric Coefficient of Variation 76.6
|
10.2 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
26.2 hour*ng/mL
Geometric Coefficient of Variation 15.6
|
40.5 hour*ng/mL
Geometric Coefficient of Variation 26.9
|
46.1 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
306.2 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
1394.7 hour*ng/mL
Geometric Coefficient of Variation 24.6
|
1299.3 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2053.6 hour*ng/mL
Geometric Coefficient of Variation 71.1
|
2171.2 hour*ng/mL
Geometric Coefficient of Variation 59.4
|
2484.5 hour*ng/mL
Geometric Coefficient of Variation 53.6
|
4906.3 hour*ng/mL
Geometric Coefficient of Variation 19.2
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2Population: The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Summarized data over Day 1 and Day 2 was reported.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=8 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 2 (With Food Effect)
Fasted
|
1509.6 hour*ng/mL
Geometric Coefficient of Variation 46.6
|
3286 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 2 (With Food Effect)
Fed
|
1458.3 hour*ng/mL
Geometric Coefficient of Variation 41.3
|
5072.9 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number analyzed" signifies those who were evaluated at the specified time point.
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=12 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Once Daily
C1D1
|
1229.3 hour*ng/mL
Geometric Coefficient of Variation 96.5
|
1544.9 hour*ng/mL
Geometric Coefficient of Variation 57.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Once Daily
C1D15
|
1532.4 hour*ng/mL
Geometric Coefficient of Variation 80.4
|
1428.8 hour*ng/mL
Geometric Coefficient of Variation 63.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Once Daily
C3D1
|
1392.3 hour*ng/mL
Geometric Coefficient of Variation 35.2
|
1122.5 hour*ng/mL
Geometric Coefficient of Variation 45.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=18 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=13 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Twice Daily
C1D1
|
407.2 hour*ng/mL
Geometric Coefficient of Variation 40.7
|
681.4 hour*ng/mL
Geometric Coefficient of Variation 43.7
|
791.1 hour*ng/mL
Geometric Coefficient of Variation 62.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Twice Daily
C1D15
|
589.3 hour*ng/mL
Geometric Coefficient of Variation 66.5
|
838.8 hour*ng/mL
Geometric Coefficient of Variation 43.9
|
710.3 hour*ng/mL
Geometric Coefficient of Variation 65.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Twice Daily
C3D1
|
450.0 hour*ng/mL
Geometric Coefficient of Variation 57.1
|
577.0 hour*ng/mL
Geometric Coefficient of Variation 72.5
|
1005.0 hour*ng/mL
Geometric Coefficient of Variation 25.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=2 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=3 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=6 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=4 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=12 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B : Regimen 1
C1D12
|
38.3 hour*ng/mL
Geometric Coefficient of Variation 254.8
|
9.4 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
43.8 hour*ng/mL
Geometric Coefficient of Variation 58.7
|
47.5 hour*ng/mL
Geometric Coefficient of Variation 68.1
|
105.6 hour*ng/mL
Geometric Coefficient of Variation 57.6
|
206.3 hour*ng/mL
Geometric Coefficient of Variation 106.5
|
805.6 hour*ng/mL
Geometric Coefficient of Variation 58.9
|
960.7 hour*ng/mL
Geometric Coefficient of Variation 46.9
|
2108.2 hour*ng/mL
Geometric Coefficient of Variation 115.0
|
2257.6 hour*ng/mL
Geometric Coefficient of Variation 30.1
|
2022.8 hour*ng/mL
Geometric Coefficient of Variation 41.3
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B : Regimen 1
C1D1
|
136.2 hour*ng/mL
Geometric Coefficient of Variation 9.2
|
6.2 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
55.5 hour*ng/mL
Geometric Coefficient of Variation 321.8
|
31.4 hour*ng/mL
Geometric Coefficient of Variation 29.7
|
61.3 hour*ng/mL
Geometric Coefficient of Variation 66.9
|
234.1 hour*ng/mL
Geometric Coefficient of Variation 70.2
|
574.2 hour*ng/mL
Geometric Coefficient of Variation 50.0
|
924.2 hour*ng/mL
Geometric Coefficient of Variation 32.7
|
1699.7 hour*ng/mL
Geometric Coefficient of Variation 36.1
|
1836.4 hour*ng/mL
Geometric Coefficient of Variation 42.8
|
2773.5 hour*ng/mL
Geometric Coefficient of Variation 54.7
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B : Regimen 1
C3D1
|
15.4 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
47.6 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
34.4 hour*ng/mL
Geometric Coefficient of Variation 37.6
|
55.5 hour*ng/mL
Geometric Coefficient of Variation 90.0
|
134.5 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
489.8 hour*ng/mL
Geometric Coefficient of Variation 55.2
|
1072.1 hour*ng/mL
Geometric Coefficient of Variation 121.6
|
—
|
1056.0 hour*ng/mL
Geometric Coefficient of Variation 26.6
|
3477.6 hour*ng/mL
Geometric Coefficient of Variation 102.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=2 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=3 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=5 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=3 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=3 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=4 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
n=14 Participants
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
n=12 Participants
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
n=5 Participants
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D1
|
—
|
23.4 hour*ng/mL
Geometric Coefficient of Variation 65.7
|
23.6 hour*ng/mL
Geometric Coefficient of Variation 22.5
|
59.1 hour*ng/mL
Geometric Coefficient of Variation 6.2
|
90.3 hour*ng/mL
Geometric Coefficient of Variation 30.8
|
218.4 hour*ng/mL
Geometric Coefficient of Variation 62.1
|
646.9 hour*ng/mL
Geometric Coefficient of Variation 20.7
|
820.4 hour*ng/mL
Geometric Coefficient of Variation 15.7
|
885.8 hour*ng/mL
Geometric Coefficient of Variation 111.0
|
1525.6 hour*ng/mL
Geometric Coefficient of Variation 13.2
|
2424.2 hour*ng/mL
Geometric Coefficient of Variation 109.7
|
2287.8 hour*ng/mL
Geometric Coefficient of Variation 77.4
|
3602.2 hour*ng/mL
Geometric Coefficient of Variation 46.2
|
4300.3 hour*ng/mL
Geometric Coefficient of Variation 54.2
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D15
|
15.7 hour*ng/mL
Geometric Coefficient of Variation 10.6
|
33.3 hour*ng/mL
Geometric Coefficient of Variation 45.8
|
21.9 hour*ng/mL
Geometric Coefficient of Variation 91.5
|
102.0 hour*ng/mL
Geometric Coefficient of Variation 63.6
|
89.7 hour*ng/mL
Geometric Coefficient of Variation 85.9
|
172.2 hour*ng/mL
Geometric Coefficient of Variation 9.0
|
669.1 hour*ng/mL
Geometric Coefficient of Variation 10.5
|
933.9 hour*ng/mL
Geometric Coefficient of Variation 15.4
|
1665.2 hour*ng/mL
Geometric Coefficient of Variation 132.1
|
1893.2 hour*ng/mL
Geometric Coefficient of Variation 17.5
|
2129.0 hour*ng/mL
Geometric Coefficient of Variation 123.7
|
2029.9 hour*ng/mL
Geometric Coefficient of Variation 63.3
|
3900.8 hour*ng/mL
Geometric Coefficient of Variation 64.3
|
6232.1 hour*ng/mL
Geometric Coefficient of Variation 7.0
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (Without Food Effect)
C3D1
|
—
|
15.4 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
41.2 hour*ng/mL
Geometric Coefficient of Variation 41.4
|
49.5 hour*ng/mL
Geometric Coefficient of Variation 17.4
|
58.1 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
415.6 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
1655.1 hour*ng/mL
Geometric Coefficient of Variation 19.1
|
1584.8 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2461.3 hour*ng/mL
Geometric Coefficient of Variation 64.3
|
2796.2 hour*ng/mL
Geometric Coefficient of Variation 59.3
|
3452.9 hour*ng/mL
Geometric Coefficient of Variation 61.6
|
5651.1 hour*ng/mL
Geometric Coefficient of Variation 23.5
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2Population: The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. Summarized data over Day 1 and Day 2 was reported.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=8 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (With Food Effect)
Fasted
|
1580.6 hour*ng/mL
Geometric Coefficient of Variation 48.7
|
3344.3 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (With Food Effect)
Fed
|
1495.7 hour*ng/mL
Geometric Coefficient of Variation 41.8
|
5633.8 hour*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=18 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=13 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Twice Daily
C1D1
|
527.6 hour*ng/mL
Geometric Coefficient of Variation 57.4
|
742.3 hour*ng/mL
Geometric Coefficient of Variation 47.1
|
939.9 hour*ng/mL
Geometric Coefficient of Variation 67.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Twice Daily
C1D15
|
674.1 hour*ng/mL
Geometric Coefficient of Variation 73.6
|
1004.2 hour*ng/mL
Geometric Coefficient of Variation 46.4
|
978.4 hour*ng/mL
Geometric Coefficient of Variation 63.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Twice Daily
C3D1
|
696.0 hour*ng/mL
Geometric Coefficient of Variation 101.4
|
700.8 hour*ng/mL
Geometric Coefficient of Variation 79.0
|
1285.7 hour*ng/mL
Geometric Coefficient of Variation 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=12 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Once Daily
C1D1
|
1253.1 hour*ng/mL
Geometric Coefficient of Variation 96.9
|
1581.4 hour*ng/mL
Geometric Coefficient of Variation 56.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Once Daily
C1D15
|
1753.9 hour*ng/mL
Geometric Coefficient of Variation 93.1
|
1517.1 hour*ng/mL
Geometric Coefficient of Variation 65.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Once Daily
C3D1
|
1597.0 hour*ng/mL
Geometric Coefficient of Variation 50.7
|
1400.3 hour*ng/mL
Geometric Coefficient of Variation 53.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. As AUCextra was \>20% of AUC0-inf, t1/2 derived from λz was regarded as implausible \& not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.
Outcome measures
| Measure |
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=2 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=3 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=6 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=4 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=10 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 1
C1D1
|
—
|
—
|
—
|
3.346 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
3.405 Hours (h)
Geometric Coefficient of Variation 52.1
|
4.599 Hours (h)
Geometric Coefficient of Variation 29.1
|
4.781 Hours (h)
Geometric Coefficient of Variation 39.4
|
5.389 Hours (h)
Geometric Coefficient of Variation 9.4
|
5.335 Hours (h)
Geometric Coefficient of Variation 23.6
|
5.351 Hours (h)
Geometric Coefficient of Variation 15.9
|
5.247 Hours (h)
Geometric Coefficient of Variation 17.1
|
—
|
—
|
—
|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 1
C1D12
|
—
|
—
|
—
|
4.985 Hours (h)
Geometric Coefficient of Variation 123.5
|
9.249 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
3.236 Hours (h)
Geometric Coefficient of Variation 19.4
|
6.750 Hours (h)
Geometric Coefficient of Variation 21.5
|
4.688 Hours (h)
Geometric Coefficient of Variation 60.4
|
6.926 Hours (h)
Geometric Coefficient of Variation 33.6
|
5.672 Hours (h)
Geometric Coefficient of Variation 15.4
|
3.964 Hours (h)
Geometric Coefficient of Variation 44.7
|
—
|
—
|
—
|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 1
C3D1
|
—
|
—
|
—
|
—
|
2.959 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2.811 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
2.931 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
2.842 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
3.038 Hours (h)
Geometric Coefficient of Variation 3.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. As AUCextra was \>20% of AUC0-inf, t1/2 derived from λz was regarded as implausible \& not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.
Outcome measures
| Measure |
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=1 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=2 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=5 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=3 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=3 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=4 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
n=14 Participants
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
n=12 Participants
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
n=5 Participants
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D1
|
—
|
—
|
—
|
—
|
2.594 Hours (h)
Geometric Coefficient of Variation 5.0
|
5.119 Hours (h)
Geometric Coefficient of Variation 30.5
|
5.115 Hours (h)
Geometric Coefficient of Variation 6.6
|
4.187 Hours (h)
Geometric Coefficient of Variation 10.3
|
3.305 Hours (h)
Geometric Coefficient of Variation 84.0
|
4.826 Hours (h)
Geometric Coefficient of Variation 14.0
|
5.057 Hours (h)
Geometric Coefficient of Variation 45.3
|
4.904 Hours (h)
Geometric Coefficient of Variation 18.8
|
5.641 Hours (h)
Geometric Coefficient of Variation 21.6
|
4.313 Hours (h)
Geometric Coefficient of Variation 29.6
|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D15
|
—
|
—
|
—
|
2.941 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2.335 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
4.443 Hours (h)
Geometric Coefficient of Variation 67.3
|
6.646 Hours (h)
Geometric Coefficient of Variation 19.5
|
5.277 Hours (h)
Geometric Coefficient of Variation 8.0
|
6.441 Hours (h)
Geometric Coefficient of Variation 28.4
|
5.193 Hours (h)
Geometric Coefficient of Variation 11.1
|
4.851 Hours (h)
Geometric Coefficient of Variation 7.9
|
5.479 Hours (h)
Geometric Coefficient of Variation 14.1
|
6.016 Hours (h)
Geometric Coefficient of Variation 18.9
|
4.847 Hours (h)
Geometric Coefficient of Variation 16.4
|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 2 (Without Food Effect)
C3D1
|
—
|
—
|
—
|
2.732 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
3.477 Hours (h)
Geometric Coefficient of Variation 11.0
|
2.853 Hours (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2.863 Hours (h)
Geometric Coefficient of Variation 22.0
|
2.418 Hours (h)
Geometric Coefficient of Variation 25.2
|
2.628 Hours (h)
Geometric Coefficient of Variation 9.4
|
2.260 Hours (h)
Geometric Coefficient of Variation 34.4
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2Population: The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. Summarized data over Day 1 and Day 2 was reported.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=8 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 2 (With Food Effect)
Fasted
|
4.898 Hour (h)
Geometric Coefficient of Variation 36.7
|
4.452 Hour (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 2 (With Food Effect)
Fed
|
4.534 Hour (h)
Geometric Coefficient of Variation 18.3
|
6.123 Hour (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=12 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Once Daily
C1D1
|
4.236 Hour (h)
Geometric Coefficient of Variation 1.3
|
4.097 Hour (h)
Geometric Coefficient of Variation 33.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Once Daily
C1D15
|
5.259 Hour (h)
Geometric Coefficient of Variation 14.8
|
5.599 Hour (h)
Geometric Coefficient of Variation 30.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Once Daily
C3D1
|
1.780 Hour (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2.680 Hour (h)
Geometric Coefficient of Variation 21.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=17 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=12 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Twice Daily
C3D1
|
3.144 Hour (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2.636 Hour (h)
Geometric Coefficient of Variation 17.0
|
3.260 Hour (h)
Geometric Coefficient of Variation 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Twice Daily
C1D1
|
2.050 Hour (h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
2.509 Hour (h)
Geometric Coefficient of Variation 25.1
|
2.814 Hour (h)
Geometric Coefficient of Variation 20.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Twice Daily
C1D15
|
2.890 Hour (h)
Geometric Coefficient of Variation 23.8
|
3.265 Hour (h)
Geometric Coefficient of Variation 18.6
|
3.210 Hour (h)
Geometric Coefficient of Variation 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. As AUCextra was \>20% of AUC0-inf, CL/f derived from λz was regarded as implausible \& not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.
Outcome measures
| Measure |
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=2 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=3 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=6 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=4 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=10 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 1
C1D1
|
—
|
—
|
—
|
132.69 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
114.26 Liter per hour
Geometric Coefficient of Variation 66.9
|
59.80 Liter per hour
Geometric Coefficient of Variation 70.2
|
48.76 Liter per hour
Geometric Coefficient of Variation 50.0
|
48.69 Liter per hour
Geometric Coefficient of Variation 32.7
|
40.01 Liter per hour
Geometric Coefficient of Variation 36.1
|
50.45 Liter per hour
Geometric Coefficient of Variation 41.2
|
47.82 Liter per hour
Geometric Coefficient of Variation 53.3
|
—
|
—
|
—
|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 1
C1D12
|
—
|
—
|
—
|
70.60 Liter per hour
Geometric Coefficient of Variation 77.3
|
44.55 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
62.53 Liter per hour
Geometric Coefficient of Variation 92.6
|
37.49 Liter per hour
Geometric Coefficient of Variation 55.2
|
49.37 Liter per hour
Geometric Coefficient of Variation 43.8
|
35.80 Liter per hour
Geometric Coefficient of Variation 99.7
|
50.88 Liter per hour
Geometric Coefficient of Variation 19.6
|
61.44 Liter per hour
Geometric Coefficient of Variation 42.3
|
—
|
—
|
—
|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 1
C3D1
|
—
|
—
|
—
|
—
|
217.56 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
104.07 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
82.35 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
107.06 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
72.25 Liter per hour
Geometric Coefficient of Variation 35.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. As AUCextra was \>20% of AUC0-inf, CL/f derived from λz was regarded as implausible \& not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.
Outcome measures
| Measure |
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=1 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=2 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=5 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=3 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=3 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=4 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
n=14 Participants
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
n=12 Participants
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
n=5 Participants
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D1
|
—
|
—
|
—
|
—
|
90.76 Liter per hour
Geometric Coefficient of Variation 18.3
|
64.09 Liter per hour
Geometric Coefficient of Variation 62.1
|
43.28 Liter per hour
Geometric Coefficient of Variation 20.7
|
54.85 Liter per hour
Geometric Coefficient of Variation 15.7
|
76.77 Liter per hour
Geometric Coefficient of Variation 111.0
|
61.61 Liter per hour
Geometric Coefficient of Variation 13.2
|
49.50 Liter per hour
Geometric Coefficient of Variation 109.7
|
65.57 Liter per hour
Geometric Coefficient of Variation 77.4
|
54.13 Liter per hour
Geometric Coefficient of Variation 46.2
|
60.63 Liter per hour
Geometric Coefficient of Variation 53.4
|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D15
|
—
|
—
|
—
|
59.55 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
134.9 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
86.72 Liter per hour
Geometric Coefficient of Variation 12.5
|
45.10 Liter per hour
Geometric Coefficient of Variation 12.7
|
49.65 Liter per hour
Geometric Coefficient of Variation 15.4
|
43.76 Liter per hour
Geometric Coefficient of Variation 122.4
|
51.47 Liter per hour
Geometric Coefficient of Variation 17.9
|
92.42 Liter per hour
Geometric Coefficient of Variation 84.1
|
81.22 Liter per hour
Geometric Coefficient of Variation 65.4
|
53.49 Liter per hour
Geometric Coefficient of Variation 64.3
|
42.20 Liter per hour
Geometric Coefficient of Variation 5.9
|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (Without Food Effect)
C3D1
|
—
|
—
|
—
|
89.34 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
41.08 Liter per hour
Geometric Coefficient of Variation 19.1
|
59.31 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
48.76 Liter per hour
Geometric Coefficient of Variation 64.3
|
61.04 Liter per hour
Geometric Coefficient of Variation 53.0
|
72.33 Liter per hour
Geometric Coefficient of Variation 63.8
|
44.23 Liter per hour
Geometric Coefficient of Variation 37.5
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2Population: The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. Summarized data over Day 1 and Day 2 was reported.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=8 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (With Food Effect)
Fasted
|
56.94 Liter per hour
Geometric Coefficient of Variation 48.7
|
44.85 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (With Food Effect)
Fed
|
60.17 Liter per hour
Geometric Coefficient of Variation 41.8
|
26.62 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=12 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Once Daily
C1D1
|
47.88 Liter per hour
Geometric Coefficient of Variation 96.9
|
56.91 Liter per hour
Geometric Coefficient of Variation 56.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Once Daily
C1D15
|
48.31 Liter per hour
Geometric Coefficient of Variation 103.9
|
62.85 Liter per hour
Geometric Coefficient of Variation 63.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Once Daily
C3D1
|
53.36 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
75.63 Liter per hour
Geometric Coefficient of Variation 59.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=17 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=12 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Twice Daily
C1D1
|
114.82 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
80.83 Liter per hour
Geometric Coefficient of Variation 47.1
|
83.86 Liter per hour
Geometric Coefficient of Variation 67.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Twice Daily
C1D15
|
71.44 Liter per hour
Geometric Coefficient of Variation 69.3
|
66.89 Liter per hour
Geometric Coefficient of Variation 52.1
|
94.48 Liter per hour
Geometric Coefficient of Variation 71.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Twice Daily
C3D1
|
126.1 Liter per hour
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
103.3 Liter per hour
Geometric Coefficient of Variation 66.9
|
77.09 Liter per hour
Geometric Coefficient of Variation 21.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. As AUCextra was \>20% of AUC0-inf, Vz/F derived from λz was regarded as implausible \& not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.
Outcome measures
| Measure |
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=2 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=3 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=6 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=4 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=10 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 1
C3D1
|
—
|
—
|
—
|
—
|
928.91 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
422.04 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
348.19 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
438.91 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
316.63 Liter
Geometric Coefficient of Variation 33.9
|
—
|
—
|
—
|
|
Apparent Volume of Distribution Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 1
C1D1
|
—
|
—
|
—
|
640.60 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
561.27 Liter
Geometric Coefficient of Variation 12.9
|
396.76 Liter
Geometric Coefficient of Variation 86.7
|
336.32 Liter
Geometric Coefficient of Variation 78.8
|
378.56 Liter
Geometric Coefficient of Variation 23.0
|
307.90 Liter
Geometric Coefficient of Variation 43.1
|
389.49 Liter
Geometric Coefficient of Variation 28.6
|
361.99 Liter
Geometric Coefficient of Variation 43.0
|
—
|
—
|
—
|
|
Apparent Volume of Distribution Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 1
C1D12
|
—
|
—
|
—
|
507.8 Liter
Geometric Coefficient of Variation 28.3
|
594.5 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
291.9 Liter
Geometric Coefficient of Variation 73.0
|
365.1 Liter
Geometric Coefficient of Variation 35.0
|
333.9 Liter
Geometric Coefficient of Variation 65.1
|
357.8 Liter
Geometric Coefficient of Variation 53.7
|
416.3 Liter
Geometric Coefficient of Variation 35.8
|
351.4 Liter
Geometric Coefficient of Variation 37.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. As AUCextra was \>20% of AUC0-inf, Vz/F derived from λz was regarded as implausible \& not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.
Outcome measures
| Measure |
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=1 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=2 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=5 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=3 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=3 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=4 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
n=14 Participants
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
n=12 Participants
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
n=5 Participants
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D1
|
—
|
—
|
—
|
—
|
339.58 Liter
Geometric Coefficient of Variation 13.2
|
473.32 Liter
Geometric Coefficient of Variation 81.2
|
319.40 Liter
Geometric Coefficient of Variation 27.0
|
331.36 Liter
Geometric Coefficient of Variation 13.3
|
366.00 Liter
Geometric Coefficient of Variation 22.8
|
428.99 Liter
Geometric Coefficient of Variation 22.7
|
361.12 Liter
Geometric Coefficient of Variation 58.1
|
463.92 Liter
Geometric Coefficient of Variation 68.7
|
440.55 Liter
Geometric Coefficient of Variation 41.7
|
377.28 Liter
Geometric Coefficient of Variation 42.4
|
|
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (Without Food Effect)
C1D15
|
—
|
—
|
—
|
252.7 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
454.6 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
555.9 Liter
Geometric Coefficient of Variation 84.7
|
432.5 Liter
Geometric Coefficient of Variation 30.7
|
378.0 Liter
Geometric Coefficient of Variation 23.6
|
406.6 Liter
Geometric Coefficient of Variation 76.5
|
385.6 Liter
Geometric Coefficient of Variation 25.9
|
646.9 Liter
Geometric Coefficient of Variation 96.3
|
642.1 Liter
Geometric Coefficient of Variation 63.5
|
464.2 Liter
Geometric Coefficient of Variation 64.9
|
295.1 Liter
Geometric Coefficient of Variation 13.4
|
|
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (Without Food Effect)
C3D1
|
—
|
—
|
—
|
352.10 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
206.07 Liter
Geometric Coefficient of Variation 30.5
|
244.16 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
201.39 Liter
Geometric Coefficient of Variation 95.6
|
212.92 Liter
Geometric Coefficient of Variation 34.4
|
274.24 Liter
Geometric Coefficient of Variation 53.8
|
144.24 Liter
Geometric Coefficient of Variation 79.1
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2Population: The food effect analysis set (FES). Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome Measure.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. Summarized data over Day 1 and Day 2 was reported.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=8 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (With Food Effect)
Fasted
|
402.4 Liter
Geometric Coefficient of Variation 49.0
|
288.1 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
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—
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—
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—
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Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (With Food Effect)
Fed
|
393.6 Liter
Geometric Coefficient of Variation 40.5
|
235.2 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
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—
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=12 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Once Daily
C1D1
|
292.61 Liter
Geometric Coefficient of Variation 99.0
|
336.38 Liter
Geometric Coefficient of Variation 47.1
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—
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Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Once Daily
C1D15
|
366.5 Liter
Geometric Coefficient of Variation 131.6
|
507.7 Liter
Geometric Coefficient of Variation 66.0
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Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Once Daily
C3D1
|
137.0 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
292.5 Liter
Geometric Coefficient of Variation 47.3
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=17 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=12 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Twice Daily
C1D1
|
339.51 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
292.59 Liter
Geometric Coefficient of Variation 42.3
|
340.43 Liter
Geometric Coefficient of Variation 57.7
|
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Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Twice Daily
C1D15
|
297.9 Liter
Geometric Coefficient of Variation 57.8
|
315.0 Liter
Geometric Coefficient of Variation 59.4
|
437.6 Liter
Geometric Coefficient of Variation 59.1
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Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Twice Daily
C3D1
|
571.8 Liter
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
392.9 Liter
Geometric Coefficient of Variation 81.9
|
362.6 Liter
Geometric Coefficient of Variation 10.2
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—
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—
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- \[AUC0-t / AUC0-inf\])\*100. %AUCextra was reported in terms of percentage of AUC0-inf.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=2 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=3 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=6 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=4 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=12 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 1
C1D1
|
81.33 Percentage of AUC 0-∞
Geometric Coefficient of Variation 21.2
|
42.23 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
43.45 Percentage of AUC 0-∞
Geometric Coefficient of Variation 79.8
|
26.80 Percentage of AUC 0-∞
Geometric Coefficient of Variation 27.3
|
13.08 Percentage of AUC 0-∞
Geometric Coefficient of Variation 47.7
|
5.31 Percentage of AUC 0-∞
Geometric Coefficient of Variation 174.3
|
5.39 Percentage of AUC 0-∞
Geometric Coefficient of Variation 112.5
|
3.52 Percentage of AUC 0-∞
Geometric Coefficient of Variation 52.0
|
4.08 Percentage of AUC 0-∞
Geometric Coefficient of Variation 47.3
|
4.09 Percentage of AUC 0-∞
Geometric Coefficient of Variation 75.2
|
5.28 Percentage of AUC 0-∞
Geometric Coefficient of Variation 155.8
|
—
|
—
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—
|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 1
C1D12
|
50.60 Percentage of AUC 0-∞
Geometric Coefficient of Variation 8.6
|
33.84 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
40.60 Percentage of AUC 0-∞
Geometric Coefficient of Variation 5.6
|
21.27 Percentage of AUC 0-∞
Geometric Coefficient of Variation 56.8
|
19.82 Percentage of AUC 0-∞
Geometric Coefficient of Variation 37.6
|
7.83 Percentage of AUC 0-∞
Geometric Coefficient of Variation 193.6
|
6.57 Percentage of AUC 0-∞
Geometric Coefficient of Variation 45.0
|
8.17 Percentage of AUC 0-∞
Geometric Coefficient of Variation 29.1
|
6.56 Percentage of AUC 0-∞
Geometric Coefficient of Variation 185.5
|
7.94 Percentage of AUC 0-∞
Geometric Coefficient of Variation 131.8
|
2.97 Percentage of AUC 0-∞
Geometric Coefficient of Variation 137.2
|
—
|
—
|
—
|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 1
C3D1
|
55.15 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
55.79 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
32.85 Percentage of AUC 0-∞
Geometric Coefficient of Variation 14.3
|
21.27 Percentage of AUC 0-∞
Geometric Coefficient of Variation 33.1
|
15.84 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
28.06 Percentage of AUC 0-∞
Geometric Coefficient of Variation 30.6
|
27.67 Percentage of AUC 0-∞
Geometric Coefficient of Variation 126.0
|
—
|
16.54 Percentage of AUC 0-∞
Geometric Coefficient of Variation 30.2
|
26.05 Percentage of AUC 0-∞
Geometric Coefficient of Variation 98.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- \[AUC0-t / AUC0-inf\])\*100. %AUCextra was reported in terms of percentage of AUC0-inf.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=2 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=3 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=3 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=3 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
n=3 Participants
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
n=5 Participants
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
n=3 Participants
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
n=3 Participants
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
n=3 Participants
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
n=3 Participants
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
n=4 Participants
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
n=14 Participants
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
n=12 Participants
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
n=5 Participants
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (Without Food Effect)
C1D1
|
—
|
55.78 Percentage of AUC 0-∞
Geometric Coefficient of Variation 11.0
|
31.63 Percentage of AUC 0-∞
Geometric Coefficient of Variation 31.2
|
27.25 Percentage of AUC 0-∞
Geometric Coefficient of Variation 15.2
|
15.10 Percentage of AUC 0-∞
Geometric Coefficient of Variation 63.9
|
12.17 Percentage of AUC 0-∞
Geometric Coefficient of Variation 59.8
|
3.29 Percentage of AUC 0-∞
Geometric Coefficient of Variation 3.7
|
1.46 Percentage of AUC 0-∞
Geometric Coefficient of Variation 30.8
|
2.66 Percentage of AUC 0-∞
Geometric Coefficient of Variation 40.8
|
2.60 Percentage of AUC 0-∞
Geometric Coefficient of Variation 33.4
|
2.94 Percentage of AUC 0-∞
Geometric Coefficient of Variation 181.0
|
2.64 Percentage of AUC 0-∞
Geometric Coefficient of Variation 68.3
|
4.36 Percentage of AUC 0-∞
Geometric Coefficient of Variation 76.2
|
3.57 Percentage of AUC 0-∞
Geometric Coefficient of Variation 149.3
|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (Without Food Effect)
C1D15
|
40.86 Percentage of AUC 0-∞
Geometric Coefficient of Variation 2.9
|
33.34 Percentage of AUC 0-∞
Geometric Coefficient of Variation 6.4
|
35.29 Percentage of AUC 0-∞
Geometric Coefficient of Variation 30.0
|
21.93 Percentage of AUC 0-∞
Geometric Coefficient of Variation 20.2
|
19.45 Percentage of AUC 0-∞
Geometric Coefficient of Variation 107.4
|
12.45 Percentage of AUC 0-∞
Geometric Coefficient of Variation 58.0
|
6.89 Percentage of AUC 0-∞
Geometric Coefficient of Variation 32.9
|
2.96 Percentage of AUC 0-∞
Geometric Coefficient of Variation 1.9
|
5.00 Percentage of AUC 0-∞
Geometric Coefficient of Variation 141.4
|
3.40 Percentage of AUC 0-∞
Geometric Coefficient of Variation 33.9
|
5.82 Percentage of AUC 0-∞
Geometric Coefficient of Variation 251.8
|
4.82 Percentage of AUC 0-∞
Geometric Coefficient of Variation 82.9
|
5.77 Percentage of AUC 0-∞
Geometric Coefficient of Variation 72.8
|
5.22 Percentage of AUC 0-∞
Geometric Coefficient of Variation 112.2
|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (Without Food Effect)
C3D1
|
—
|
33.93 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
33.77 Percentage of AUC 0-∞
Geometric Coefficient of Variation 47.7
|
17.27 Percentage of AUC 0-∞
Geometric Coefficient of Variation 45.0
|
20.68 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
26.32 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
15.35 Percentage of AUC 0-∞
Geometric Coefficient of Variation 29.7
|
18.02 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
16.22 Percentage of AUC 0-∞
Geometric Coefficient of Variation 26.9
|
17.54 Percentage of AUC 0-∞
Geometric Coefficient of Variation 83.4
|
23.45 Percentage of AUC 0-∞
Geometric Coefficient of Variation 59.4
|
11.15 Percentage of AUC 0-∞
Geometric Coefficient of Variation 77.4
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2Population: The food effect analysis set (FES). Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome Measure.
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- \[AUC0-t / AUC0-inf\])\*100. AUCextra was reported in terms of percentage of AUC0-inf. Summarized data over Day 1 and Day 2 was reported.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=8 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=1 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (With Food Effect)
Fasted
|
2.54 Percentage of AUC 0-∞
Geometric Coefficient of Variation 149.8
|
1.74 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (With Food Effect)
Fed
|
2.21 Percentage of AUC 0-∞
Geometric Coefficient of Variation 56.3
|
9.96 Percentage of AUC 0-∞
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- \[AUC0-t / AUC0-inf\])\*100. AUCextra was reported in terms of percentage of AUC0-inf.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=12 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Once Daily
C1D1
|
1.88 percentage of AUC 0-∞
Geometric Coefficient of Variation 16.2
|
2.11 percentage of AUC 0-∞
Geometric Coefficient of Variation 50.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Once Daily
C1D15
|
7.95 percentage of AUC 0-∞
Geometric Coefficient of Variation 149.3
|
4.28 percentage of AUC 0-∞
Geometric Coefficient of Variation 85.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Once Daily
C3D1
|
9.11 percentage of AUC 0-∞
Geometric Coefficient of Variation 171.3
|
17.56 percentage of AUC 0-∞
Geometric Coefficient of Variation 50.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1Population: PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- \[AUC0-t / AUC0-inf\])\*100. AUCextra was reported in terms of percentage of AUC0-inf.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=3 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=18 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=13 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Twice Daily
C1D1
|
16.82 Percentage of AUC 0-∞
Geometric Coefficient of Variation 128.4
|
7.70 Percentage of AUC 0-∞
Geometric Coefficient of Variation 58.3
|
10.90 Percentage of AUC 0-∞
Geometric Coefficient of Variation 68.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Twice Daily
C1D15
|
11.78 Percentage of AUC 0-∞
Geometric Coefficient of Variation 42.8
|
14.14 Percentage of AUC 0-∞
Geometric Coefficient of Variation 51.4
|
19.19 Percentage of AUC 0-∞
Geometric Coefficient of Variation 79.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Twice Daily
C3D1
|
30.63 Percentage of AUC 0-∞
Geometric Coefficient of Variation 70.7
|
16.43 Percentage of AUC 0-∞
Geometric Coefficient of Variation 37.5
|
21.34 Percentage of AUC 0-∞
Geometric Coefficient of Variation 21.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on C1D1, C1D2, C1D5, C1D8; 2, 4, 8 h post-dose on C1D1; pre-dose, 2, 8, 24 h post-dose on C1D12-15; pre-dose, 2, 4 h post-dose on C1D3Population: Analysis population included subjects from safety analysis set having at least one pERK/tot ERK sample and not excluded from the analysis as per SAP. Number analyzed= subjects who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=41 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=76 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=12 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=31 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D1, Pre-dose (pERK)
|
4.524 fold change
Standard Deviation 1.839
|
3.937 fold change
Standard Deviation 1.662
|
4.121 fold change
Standard Deviation 1.743
|
3.629 fold change
Standard Deviation 1.491
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D1, 2 h post-dose (pERK)
|
1.235 fold change
Standard Deviation 0.295
|
1.305 fold change
Standard Deviation 0.755
|
1.178 fold change
Standard Deviation 0.194
|
1.249 fold change
Standard Deviation 0.219
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D1, 4 h post-dose (pERK)
|
3.828 fold change
Standard Deviation 1.715
|
3.422 fold change
Standard Deviation 1.902
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D1, 8 h post-dose (pERK)
|
1.454 fold change
Standard Deviation 0.515
|
1.454 fold change
Standard Deviation 0.403
|
1.878 fold change
Standard Deviation 0.836
|
1.821 fold change
Standard Deviation 0.514
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D2, Pre-dose (pERK)
|
2.853 fold change
Standard Deviation 1.399
|
2.411 fold change
Standard Deviation 1.031
|
3.081 fold change
Standard Deviation 1.249
|
2.069 fold change
Standard Deviation 0.748
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D5, Pre-dose (pERK)
|
2.722 fold change
Standard Deviation 1.326
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D8, Pre-dose (pERK)
|
4.48 fold change
Standard Deviation 2.119
|
2.868 fold change
Standard Deviation 1.473
|
2.541 fold change
Standard Deviation 1.338
|
2.235 fold change
Standard Deviation 0.739
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D12-15, Pre-dose (pERK)
|
3.257 fold change
Standard Deviation 1.671
|
3.265 fold change
Standard Deviation 1.845
|
3.241 fold change
Standard Deviation 2.249
|
2.16 fold change
Standard Deviation 0.814
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D12-15, 2 h Post-dose (pERK)
|
1.252 fold change
Standard Deviation 0.217
|
1.293 fold change
Standard Deviation 0.447
|
1.471 fold change
Standard Deviation 0.529
|
1.315 fold change
Standard Deviation 0.218
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D12-15, 8 h Post-dose (pERK)
|
1.514 fold change
Standard Deviation 0.391
|
1.653 fold change
Standard Deviation 0.571
|
1.902 fold change
Standard Deviation 0.87
|
1.98 fold change
Standard Deviation 0.827
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D12-15, 24 h Post-dose (pERK)
|
2.768 fold change
Standard Deviation 1.594
|
2.476 fold change
Standard Deviation 0.958
|
2.598 fold change
Standard Deviation 1.185
|
2.043 fold change
Standard Deviation 0.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C3D1, Pre-dose (pERK)
|
5.179 fold change
Standard Deviation 2.151
|
3.716 fold change
Standard Deviation 1.875
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C3D1, 2 h Post-dose (pERK)
|
1.795 fold change
Standard Deviation 0.687
|
1.288 fold change
Standard Deviation 0.327
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C3D1, 4 h Post-dose (pERK)
|
3.106 fold change
Standard Deviation 0.461
|
2.688 fold change
Standard Deviation 2.065
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D1, Pre-dose (Tot ERK)
|
1.1 fold change
Standard Deviation 0.468
|
1.075 fold change
Standard Deviation 0.25
|
1.02 fold change
Standard Deviation 0.169
|
1.086 fold change
Standard Deviation 0.277
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D1, 2 h post-dose (Tot ERK)
|
1.063 fold change
Standard Deviation 0.215
|
1.069 fold change
Standard Deviation 0.247
|
1.078 fold change
Standard Deviation 0.151
|
1.079 fold change
Standard Deviation 0.193
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D1, 4 h post-dose (Tot ERK)
|
1.059 fold change
Standard Deviation 0.621
|
1.012 fold change
Standard Deviation 0.286
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D1, 8 h post-dose (Tot ERK)
|
1.058 fold change
Standard Deviation 0.16
|
1.095 fold change
Standard Deviation 0.31
|
1.078 fold change
Standard Deviation 0.143
|
1.098 fold change
Standard Deviation 0.161
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D2, Pre-dose (Tot ERK)
|
1.075 fold change
Standard Deviation 0.103
|
1.13 fold change
Standard Deviation 0.455
|
1.013 fold change
Standard Deviation 0.273
|
1.108 fold change
Standard Deviation 0.154
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D5, Pre-dose (Tot ERK)
|
1.163 fold change
Standard Deviation 0.146
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D8, Pre-dose (Tot ERK)
|
1.233 fold change
Standard Deviation 0.674
|
1.108 fold change
Standard Deviation 0.353
|
0.944 fold change
Standard Deviation 0.117
|
1.049 fold change
Standard Deviation 0.133
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D12-15, Pre-dose (Tot ERK)
|
1.223 fold change
Standard Deviation 0.476
|
1.118 fold change
Standard Deviation 0.268
|
1.333 fold change
Standard Deviation 0.878
|
1.047 fold change
Standard Deviation 0.144
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D12-15, 2 h Post-dose (Tot ERK)
|
1.04 fold change
Standard Deviation 0.102
|
1.125 fold change
Standard Deviation 0.34
|
1.335 fold change
Standard Deviation 0.754
|
1.059 fold change
Standard Deviation 0.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D12-15, 8 h Post-dose (Tot ERK)
|
0.994 fold change
Standard Deviation 0.165
|
1.041 fold change
Standard Deviation 0.237
|
1.044 fold change
Standard Deviation 0.238
|
1.026 fold change
Standard Deviation 0.146
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C1D12-15, 24 h Post-dose (Tot ERK)
|
1.047 fold change
Standard Deviation 0.153
|
1.045 fold change
Standard Deviation 0.183
|
1.048 fold change
Standard Deviation 0.139
|
1.068 fold change
Standard Deviation 0.141
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C3D1, Pre-dose (Tot ERK)
|
1.074 fold change
Standard Deviation 0.34
|
1.138 fold change
Standard Deviation 0.306
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C3D1, 2 h Post-dose (Tot ERK)
|
1.087 fold change
Standard Deviation 0.413
|
1.251 fold change
Standard Deviation 0.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
|
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
C3D1, 4 h Post-dose (Tot ERK)
|
0.674 fold change
Standard Deviation 0.304
|
1.052 fold change
Standard Deviation 0.182
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Baseline until disease progression (assessed up to end of treatment [253 weeks])Population: The SAF included all subjects who received at least 1 administration of MSC1936369B. Here "Number of Subjects analysed" = subjects evaluable for this endpoint.
Number of subjects with clinical benefit (CR, PR, or SD) and PD according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.
Outcome measures
| Measure |
MSC1936369B Regimen 1
n=39 Participants
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=71 Participants
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=15 Participants
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=33 Participants
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Clinical Benefit (Complete Response [CR], Partial Response [PR] or Stable Disease [SD}) and Progressive Disease (PD) Based on the Best Overall Response (BOR)
CR
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Benefit (Complete Response [CR], Partial Response [PR] or Stable Disease [SD}) and Progressive Disease (PD) Based on the Best Overall Response (BOR)
PR
|
0 Subjects
|
4 Subjects
|
2 Subjects
|
6 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Benefit (Complete Response [CR], Partial Response [PR] or Stable Disease [SD}) and Progressive Disease (PD) Based on the Best Overall Response (BOR)
SD
|
19 Subjects
|
34 Subjects
|
9 Subjects
|
14 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Clinical Benefit (Complete Response [CR], Partial Response [PR] or Stable Disease [SD}) and Progressive Disease (PD) Based on the Best Overall Response (BOR)
PD
|
20 Subjects
|
33 Subjects
|
4 Subjects
|
12 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
MSC1936369B Regimen 1
Serious events: 23 serious events
Other events: 47 other events
Deaths: 0 deaths
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
Serious events: 45 serious events
Other events: 80 other events
Deaths: 0 deaths
MSC1936369B Regimen 3 Once Daily (QD)
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
MSC1936369B Regimen 3 Twice Daily
Serious events: 21 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MSC1936369B Regimen 1
n=49 participants at risk
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=82 participants at risk
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=15 participants at risk
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=34 participants at risk
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|
|
General disorders
General physical health deterioration
|
14.3%
7/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
15.9%
13/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Pyrexia
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Asthenia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Chest pain
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Hyperthermia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Disease progression
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Fatigue
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Obstruction
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Oedema peripheral
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Device occlusion
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Malaise
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal detachment
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Choroiditis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Macular degeneration
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal vein occlusion
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal vein thrombosis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Visual acuity reduced
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Visual impairment
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Macular oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Vision blurred
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Haematemesis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Subileus
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.8%
4/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Hepatobiliary disorders
Hepatic failure
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Sepsis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Septic shock
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Leukoencephalopathy
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Headache
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Seizure
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial neoplasm
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Thrombophlebitis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Hypertension
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.8%
3/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypoventilation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Congenital, familial and genetic disorders
Ichthyosis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Macular detachment
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Abscess
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastasis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
Other adverse events
| Measure |
MSC1936369B Regimen 1
n=49 participants at risk
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
n=82 participants at risk
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
|
MSC1936369B Regimen 3 Once Daily (QD)
n=15 participants at risk
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
MSC1936369B Regimen 3 Twice Daily
n=34 participants at risk
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
|
|---|---|---|---|---|
|
General disorders
Localised oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Feeling cold
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Hepatobiliary disorders
Hepatic pain
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Hepatobiliary disorders
Cholestasis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Hepatobiliary disorders
Jaundice
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Injection site oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Hypertension
|
14.3%
7/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.8%
4/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Hot flush
|
8.2%
4/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Hypotension
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Lymphoedema
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Thrombosis
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Thrombophlebitis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Vascular compression
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Flushing
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Vascular disorders
Haematoma
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.0%
1/49 • Number of events 1 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Number of events 2 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Number of events 1 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Number of events 1 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Number of events 1 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Number of events 1 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Number of events 1 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Asthenia
|
55.1%
27/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
46.3%
38/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
53.3%
8/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
35.3%
12/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Oedema peripheral
|
24.5%
12/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
36.6%
30/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
60.0%
9/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
61.8%
21/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Pyrexia
|
18.4%
9/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
15.9%
13/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
20.0%
3/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
35.3%
12/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Fatigue
|
12.2%
6/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
19.5%
16/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
23.5%
8/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Non-cardiac chest pain
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Chest pain
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Chills
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.8%
4/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Hyperthermia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Inflammation
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Influenza like illness
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Mucosal inflammation
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.8%
3/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Nodule
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Pain
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Systemic inflammatory response syndrome
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Face oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
23.5%
8/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Generalised oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Hypothermia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Mucosal dryness
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Peripheral swelling
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Thrombosis in device
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
Xerosis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.8%
4/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
General disorders
General physical health deterioration
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Psychiatric disorders
Depression
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
7.3%
6/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.8%
4/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.5%
7/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Psychiatric disorders
Illusion
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Ovarian vein thrombosis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Reproductive system and breast disorders
Scrotal erythema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Burn of internal organs
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Burn oesophageal
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Weight decreased
|
12.2%
6/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
9.8%
8/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
26.7%
4/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Ejection fraction decreased
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.7%
5/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood 25-hydroxycholecalciferol decreased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood albumin decreased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood parathyroid hormone increased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood potassium increased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Electrocardiogram qt prolonged
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Haemoglobin decreased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Heart rate increased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Weight increased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.8%
3/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Cardiac murmur
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Electrocardiogram pr prolongation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Platelet count decreased
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Investigations
Retinogram abnormal
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Tachycardia
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Aortic valve incompetence
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Congenital, familial and genetic disorders
Colour blindness
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.4%
10/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
26.8%
22/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
20.0%
3/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
7.3%
6/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
7.3%
6/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.2%
6/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.6%
12/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
26.7%
4/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.6%
6/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.7%
5/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Visual field defect
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.5%
7/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.7%
5/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Dysgeusia
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.7%
5/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Headache
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.6%
12/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.8%
4/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Somnolence
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Amnesia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Dysaesthesia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Neurotoxicity
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Sciatica
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Speech disorder
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.7%
5/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Apraxia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Vision blurred
|
14.3%
7/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
24.4%
20/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.6%
6/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Visual impairment
|
10.2%
5/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Colour blindness acquired
|
8.2%
4/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Macular detachment
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.1%
14/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
60.0%
9/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
47.1%
16/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal detachment
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.4%
11/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
20.0%
3/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
29.4%
10/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Eyelid oedema
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.1%
5/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.6%
6/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Photopsia
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal vein occlusion
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Visual acuity reduced
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.1%
5/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Altered visual depth perception
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Chromatopsia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Corneal epithelium defect
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Diplopia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Eye pain
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Lacrimation increased
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Macular oedema
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Metamorphopsia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Ocular hyperaemia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Ocular icterus
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Ulcerative keratitis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Keratitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal exudates
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Cataract
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Choroidal haemorrhage
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.8%
3/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Eye swelling
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Growth of eyelashes
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.8%
4/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Eyelash discolouration
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Maculopathy
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Trichomegaly
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Retinal haemorrhage
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.8%
3/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Dry eye
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Eye oedema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Ear and labyrinth disorders
Vertigo
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.1%
5/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Diarrhoea
|
51.0%
25/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
56.1%
46/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
93.3%
14/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
85.3%
29/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
21/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
31.7%
26/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
40.0%
6/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
44.1%
15/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Vomiting
|
30.6%
15/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
34.1%
28/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
32.4%
11/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Stomatitis
|
20.4%
10/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.6%
12/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
23.5%
8/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.4%
9/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
20.7%
17/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
29.4%
10/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Constipation
|
18.4%
9/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
20.7%
17/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
33.3%
5/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
26.5%
9/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Dry mouth
|
12.2%
6/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
7.3%
6/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Ascites
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.5%
7/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.6%
6/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Anal fistula
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Faeces discoloured
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Melaena
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Oesophagitis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Aptyalism
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Renal and urinary disorders
Chromaturia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Renal and urinary disorders
Hydronephrosis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Hepatobiliary disorders
Portal hypertension
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Acne
|
18.4%
9/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
15.9%
13/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.4%
9/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
22.0%
18/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
40.0%
6/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
41.2%
14/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.3%
7/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
23.2%
19/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
46.7%
7/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
35.3%
12/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
7/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.0%
9/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
26.7%
4/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.6%
6/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
6/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
15.9%
13/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
40.0%
6/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.6%
6/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
26.7%
4/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.6%
6/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.6%
6/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
20.0%
3/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.8%
3/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.8%
4/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.8%
3/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Nail pigmentation
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
4/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.5%
7/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.7%
5/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.0%
9/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
17.6%
6/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.5%
7/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
11.8%
4/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.7%
5/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.8%
3/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Pubic pain
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.5%
13/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.4%
11/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
29.4%
10/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.2%
4/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
12.2%
10/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.5%
7/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
3.7%
3/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
12.2%
10/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Lymphangitis
|
6.1%
3/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Bronchitis
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
8.8%
3/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
2/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Erysipelas
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Folliculitis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Fungal infection
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Herpes zoster
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Influenza
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Nosocomial infection
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Otitis media
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Paronychia
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
13.3%
2/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.7%
5/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
4.9%
4/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Rhinitis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.1%
5/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
14.7%
5/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.4%
2/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Anal infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Furuncle
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Ear infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Eye infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Lung infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
5.9%
2/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Skin infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
0.00%
0/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
|
Infections and infestations
Cystitis
|
2.0%
1/49 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
1.2%
1/82 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
6.7%
1/15 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
2.9%
1/34 • Baseline up to 253 weeks
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER