Trial Outcomes & Findings for MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma (NCT NCT02551055)
NCT ID: NCT02551055
Last Updated: 2019-09-20
Results Overview
Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of following considered related to any of treatment by investigator: Grade 4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>7 days; ≥ Grade 3 neutropenia with coincident fever or infection; Grade 4 thrombocytopenia for \>7 days; Grade 3 thrombocytopenia with clinically significant bleeding; Platelet count \<10,000/mm\^3 at any time; Delay in initiation of subsequent therapy cycle by \>7 days due to treatment-related toxicity; ≥Grade 3 nonhematological toxicity except Grade 3 arthralgia/myalgia, fatigue that lasts \<1 month, diarrhea, fasting hyperglycemia lasting ≤14 days, rash lasting ≤7 days and any other Grade 3 nonhematological toxicity that could be safely, reliably controlled to ≤Grade 1 with appropriate treatment; ≥ Grade 2 nonhematologic toxicities that are considered by investigator to be related to study drugs and dose-limiting.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Up to Cycle 1 (28 days for MLN1117+TAK-659, MLN1117+Alisertib, MLN1117+Paclitaxel or 21 days for MLN1117+Docetaxel)
Results posted on
2019-09-20
Participant Flow
Participants took part in the study at 3 investigative sites in Spain and the United States from 15 October 2015 to 18 January 2017.
Participants with solid advanced tumors were enrolled in Part 1 to receive MLN1117 along with alisertib, paclitaxel, TAK-659 and docetaxel in 1 of 7 treatment regimens. In Part 2, participants with gastric or gastroesophageal junction adenocarcinoma were to be enrolled, however, study terminated before initiation of part 2.
Participant milestones
| Measure |
MLN1117 300 mg + Alisertib
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
3
|
6
|
7
|
2
|
4
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
2
|
5
|
7
|
1
|
3
|
0
|
Reasons for withdrawal
| Measure |
MLN1117 300 mg + Alisertib
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
4
|
2
|
2
|
2
|
1
|
2
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
1
|
0
|
2
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Reason not specified
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
MLN1117 300 mg + Alisertib
n=4 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 Participants
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 Participants
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 4.86 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 13.28 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 11.82 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 9.16 • n=21 Participants
|
65.5 years
STANDARD_DEVIATION 4.95 • n=8 Participants
|
62.3 years
STANDARD_DEVIATION 9.95 • n=8 Participants
|
62.0 years
STANDARD_DEVIATION 8.61 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
3 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
6 participants
n=21 Participants
|
2 participants
n=8 Participants
|
3 participants
n=8 Participants
|
29 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
1 participants
n=8 Participants
|
4 participants
n=8 Participants
|
27 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
4 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
2 participants
n=8 Participants
|
4 participants
n=8 Participants
|
27 participants
n=24 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
5 participants
n=24 Participants
|
|
Height
|
162.90 cm
STANDARD_DEVIATION 14.178 • n=5 Participants
|
165.50 cm
STANDARD_DEVIATION 10.145 • n=7 Participants
|
159.80 cm
STANDARD_DEVIATION 4.513 • n=5 Participants
|
162.83 cm
STANDARD_DEVIATION 15.108 • n=4 Participants
|
158.76 cm
STANDARD_DEVIATION 6.662 • n=21 Participants
|
154.95 cm
STANDARD_DEVIATION 7.142 • n=8 Participants
|
166.25 cm
STANDARD_DEVIATION 16.674 • n=8 Participants
|
162.07 cm
STANDARD_DEVIATION 10.939 • n=24 Participants
|
|
Weight
|
77.75 kg
STANDARD_DEVIATION 15.314 • n=5 Participants
|
71.63 kg
STANDARD_DEVIATION 19.725 • n=7 Participants
|
74.07 kg
STANDARD_DEVIATION 12.756 • n=5 Participants
|
82.38 kg
STANDARD_DEVIATION 25.474 • n=4 Participants
|
65.53 kg
STANDARD_DEVIATION 13.046 • n=21 Participants
|
75.45 kg
STANDARD_DEVIATION 43.911 • n=8 Participants
|
68.28 kg
STANDARD_DEVIATION 21.403 • n=8 Participants
|
73.13 kg
STANDARD_DEVIATION 19.400 • n=24 Participants
|
|
Body Surface Area
|
1.825 m^2
STANDARD_DEVIATION 0.2814 • n=5 Participants
|
1.802 m^2
STANDARD_DEVIATION 0.2863 • n=7 Participants
|
1.809 m^2
STANDARD_DEVIATION 0.1638 • n=5 Participants
|
1.917 m^2
STANDARD_DEVIATION 0.3496 • n=4 Participants
|
1.694 m^2
STANDARD_DEVIATION 0.1790 • n=21 Participants
|
1.768 m^2
STANDARD_DEVIATION 0.5769 • n=8 Participants
|
1.767 m^2
STANDARD_DEVIATION 0.3734 • n=8 Participants
|
1.796 m^2
STANDARD_DEVIATION 0.2796 • n=24 Participants
|
PRIMARY outcome
Timeframe: Up to Cycle 1 (28 days for MLN1117+TAK-659, MLN1117+Alisertib, MLN1117+Paclitaxel or 21 days for MLN1117+Docetaxel)Population: DLT-evaluable population defined as all participants in Part 1 of study who either experience DLT during Cycle 1 or complete treatment with at least 75% of the planned doses of MLN1117 and the combination partner, and have sufficient follow-up data for the investigators and sponsor to determine whether DLT occurred.
Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of following considered related to any of treatment by investigator: Grade 4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>7 days; ≥ Grade 3 neutropenia with coincident fever or infection; Grade 4 thrombocytopenia for \>7 days; Grade 3 thrombocytopenia with clinically significant bleeding; Platelet count \<10,000/mm\^3 at any time; Delay in initiation of subsequent therapy cycle by \>7 days due to treatment-related toxicity; ≥Grade 3 nonhematological toxicity except Grade 3 arthralgia/myalgia, fatigue that lasts \<1 month, diarrhea, fasting hyperglycemia lasting ≤14 days, rash lasting ≤7 days and any other Grade 3 nonhematological toxicity that could be safely, reliably controlled to ≤Grade 1 with appropriate treatment; ≥ Grade 2 nonhematologic toxicities that are considered by investigator to be related to study drugs and dose-limiting.
Outcome measures
| Measure |
MLN1117 300 mg + Alisertib
n=4 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 Participants
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 Participants
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Cycle 1 Dose Limiting Toxicity (DLT) in Part 1
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)Population: Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
MLN1117 300 mg + Alisertib
n=4 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 Participants
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 Participants
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE) in Part 1
|
4 participants
|
6 participants
|
3 participants
|
6 participants
|
7 participants
|
2 participants
|
4 participants
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)Population: Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. There are 5 grades of the CTCAE; "grade" refers to severity. Grade 5 is the most severe, grade 1 is the least severe. As per version 4.0 of the CTCAE, Grade 3 = AE with severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 = AE with life-threatening consequences; urgent intervention indicated and Grade 5 = Death related to AE.
Outcome measures
| Measure |
MLN1117 300 mg + Alisertib
n=4 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 Participants
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 Participants
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least 1 ≥ Grade 3 TEAE in Part 1
|
4 participants
|
4 participants
|
2 participants
|
2 participants
|
6 participants
|
2 participants
|
4 participants
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)Population: Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; or a medically important event. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
MLN1117 300 mg + Alisertib
n=4 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 Participants
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 Participants
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least 1 Treatment-Emergent Serious Adverse Event (SAE) in Part 1
|
2 participants
|
3 participants
|
1 participants
|
2 participants
|
5 participants
|
2 participants
|
4 participants
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)Population: Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.
A decision regarding which study drug requires dose modification is dependent upon the toxicity, its onset, and time course. The causal relationship of each AE should will be assessed in relation to MLN1117 and to the combination agent in each cohort so that dose modifications can be made accordingly. Intrapatient dose reductions of MLN1117 are not permitted during Part 1 Cycle 1 unless the participant experiences a DLT attributed to MLN1117. Per dose modification guidelines, participants who have the study drug held because of treatment related or possibly related AEs may resume study drug treatment after resolution of the AE but may either maintain the same dose level or have doses of study drug reduced (dose reduction) by at least 1 dose level and if needed, by 2 dose levels. When a dose reduction of MLN1117 occurs, the MLN1117 dose will be reduced to the next lower dose that has been established as a safe dose during dose escalation (Part 1).
Outcome measures
| Measure |
MLN1117 300 mg + Alisertib
n=4 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 Participants
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 Participants
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least 1 Dose Modification Due to AE in Part 1
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
4 participants
|
0 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)Population: Study was terminated before the initiation of Part 2 of the study.
Overall response is defined as complete response (CR) plus partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) version 1.1 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)Population: Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; or a medically important event. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
MLN1117 300 mg + Alisertib
n=4 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 Participants
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 Participants
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least 1 TEAE and Serious TEAE in Part 1 and 2
SAE
|
2 participants
|
3 participants
|
1 participants
|
2 participants
|
5 participants
|
2 participants
|
4 participants
|
—
|
|
Number of Participants With at Least 1 TEAE and Serious TEAE in Part 1 and 2
AE
|
4 participants
|
6 participants
|
3 participants
|
6 participants
|
7 participants
|
2 participants
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)Population: Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.
Per dose modification guidelines, participants who have the study drug held because of treatment related or possibly related AEs may resume study drug treatment after resolution of the AE but may either maintain the same dose level or have doses of study drug reduced (dose reduction) by at least 1 dose level and if needed, by 2 dose levels.
Outcome measures
| Measure |
MLN1117 300 mg + Alisertib
n=4 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 Participants
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 Participants
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Delays, Dose Reductions, and Dose Interruptions Due To AE in Part 1 and 2
Dose delay due to AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Dose Delays, Dose Reductions, and Dose Interruptions Due To AE in Part 1 and 2
Dose reduction due to AE
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Dose Delays, Dose Reductions, and Dose Interruptions Due To AE in Part 1 and 2
Dose interruption due to AE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)Population: Study was terminated before the initiation of Part 2 of the study.
PFS is defined as the time from the date of randomization to the date of first documentation of Progressive disease (PD) or death due to any cause, whichever occurs first. PD is defined as an increase of \>=20% from the nadir (or baseline, if it represents the point at which the sum of target disease was lowest).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)Population: Study was terminated before the initiation of Part 2 of the study.
Disease control rate is defined as the percentage of participants with complete response (CR) + Partial response (PR) + stable disease (SD) according to RECIST version 1.1 criteria. CR is defined as disappearance of all target lesions, PR is defined as 30% decrease in the sum of the longest diameter of target lesions and SD is defined as not qualifying for CR, PR, or PD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)Population: Study was terminated before the initiation of Part 2 of the study.
DOR is defined as the time from the date of first documentation of a response to the date of first documentation of PD according to RECIST version 1.1 criteria. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)Population: Study was terminated before the initiation of Part 2 of the study.
TTP is defined as the time from the date of randomization to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization up to end of Part 2, then every 12 weeks until participant death or until 1 year after the last dose of study drug, whichever occurs first (up to 336 days)Population: Study was terminated before the initiation of Part 2 of the study.
OS is defined as the time from the date of randomization to the date of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: MLN1117 300 mg + Alisertib arms: Cycle 1 Day 3; MLN1117 300 mg + Paclitaxel arms and MLN1117 200 mg + Docetaxel arms: Cycle 1 Day 2; MLN1117 300 mg + TAK-659 arm: Cycle 1 Days 1 and 17Population: Pharmacokinetic (PK) evaluable population included all participants in Part 1 (dose escalation of the study for whom there were sufficient dosing and MLN1117 concentration-time data was available).
Outcome measures
| Measure |
MLN1117 300 mg + Alisertib
n=4 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 Participants
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 Participants
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 Participants
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 Participants
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
Part 2
Participants entered Part 2 of the study were to be screened to determine EBV-positive or EBV-negative solid tumors. EBV-positive participants were to receive MLN1117+TAK-659 (Cohort A). EBV-negative participants were to be randomized to other treatment cohorts: MLN1117+alisertib (Cohort B), MLN1117+paclitaxel (Cohort C), or MLN1117+docetaxel (Cohort D).
|
|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration of MLN1117-1003
Day 1: Predose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
0.00 ng/mL
Standard Deviation 0.000
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 2: 4 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3206.67 ng/mL
Standard Deviation 256.970
|
3994.67 ng/mL
Standard Deviation 3191.500
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3725.00 ng/mL
Standard Deviation 3542.605
|
1475.75 ng/mL
Standard Deviation 1062.242
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 2: 6 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
2720.00 ng/mL
Standard Deviation 10.000
|
4311.67 ng/mL
Standard Deviation 2752.595
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3085.00 ng/mL
Standard Deviation 2920.351
|
1417.75 ng/mL
Standard Deviation 907.208
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 1: 0.5 Hour Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
675.04 ng/mL
Standard Deviation 816.641
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 1: 1 Hour Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
2171.00 ng/mL
Standard Deviation 1840.041
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 1: 2 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3054.14 ng/mL
Standard Deviation 1811.084
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 2: 8 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
2536.67 ng/mL
Standard Deviation 87.369
|
3246.00 ng/mL
Standard Deviation 2026.285
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3025.00 ng/mL
Standard Deviation 2807.214
|
1443.25 ng/mL
Standard Deviation 992.241
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 2: 24 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
592.67 ng/mL
Standard Deviation 38.527
|
1279.83 ng/mL
Standard Deviation 1238.550
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
717.00 ng/mL
Standard Deviation 668.923
|
420.80 ng/mL
Standard Deviation 477.731
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 3: Predose
|
2177.50 ng/mL
Standard Deviation 1453.717
|
3178.82 ng/mL
Standard Deviation 2696.065
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 1: 3 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3315.29 ng/mL
Standard Deviation 1521.130
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 1: 4 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3164.71 ng/mL
Standard Deviation 1522.096
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 1: 6 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
2726.71 ng/mL
Standard Deviation 1259.976
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 1: 8 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
2466.29 ng/mL
Standard Deviation 1112.350
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 1: 24 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
1045.17 ng/mL
Standard Deviation 642.781
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 2: Predose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
0.00 ng/mL
Standard Deviation 0.000
|
0.00 ng/mL
Standard Deviation 0.000
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
0.00 ng/mL
Standard Deviation 0.000
|
0.00 ng/mL
Standard Deviation 0.000
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 2: 0.5 Hour Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
1762.00 ng/mL
Standard Deviation 1295.728
|
1701.17 ng/mL
Standard Deviation 1407.015
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3240.00 ng/mL
Standard Deviation 1230.366
|
1333.05 ng/mL
Standard Deviation 1970.336
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 2: 1 Hour Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3840.00 ng/mL
Standard Deviation 747.195
|
3261.83 ng/mL
Standard Deviation 2879.952
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3165.00 ng/mL
Standard Deviation 1859.691
|
1554.00 ng/mL
Standard Deviation 2042.092
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 2: 2 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
4066.67 ng/mL
Standard Deviation 322.542
|
3934.00 ng/mL
Standard Deviation 3419.860
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
4615.00 ng/mL
Standard Deviation 4433.560
|
1456.23 ng/mL
Standard Deviation 1577.178
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 2: 3 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
3653.33 ng/mL
Standard Deviation 325.628
|
3753.50 ng/mL
Standard Deviation 3324.071
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
4355.00 ng/mL
Standard Deviation 4362.849
|
1598.75 ng/mL
Standard Deviation 1269.397
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 3: 0.5 Hour Postdose
|
3225.00 ng/mL
Standard Deviation 693.229
|
4554.80 ng/mL
Standard Deviation 3431.547
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 3: 1 Hour Postdose
|
5010.00 ng/mL
Standard Deviation 1376.590
|
5070.60 ng/mL
Standard Deviation 3278.807
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 3: 2 Hours Postdose
|
5007.50 ng/mL
Standard Deviation 1192.347
|
6235.80 ng/mL
Standard Deviation 4139.804
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 3: 3 Hours Postdose
|
4815.00 ng/mL
Standard Deviation 810.535
|
5650.00 ng/mL
Standard Deviation 3995.103
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 3: 4 Hours Postdose
|
4797.50 ng/mL
Standard Deviation 1240.225
|
4719.20 ng/mL
Standard Deviation 3100.983
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 3: 6 Hours Postdose
|
4777.50 ng/mL
Standard Deviation 1753.024
|
4501.80 ng/mL
Standard Deviation 2904.730
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 3: 8 Hours Postdose
|
4320.00 ng/mL
Standard Deviation 1862.078
|
4354.80 ng/mL
Standard Deviation 2836.444
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 3: 24 Hours Postdose
|
2217.33 ng/mL
Standard Deviation 1604.245
|
2357.42 ng/mL
Standard Deviation 1806.031
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 17: Predose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
978.33 ng/mL
Standard Deviation 1519.070
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 17: 0.5 Hour Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
2893.67 ng/mL
Standard Deviation 1738.859
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 17: 1 Hour Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
5596.67 ng/mL
Standard Deviation 387.599
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 17: 2 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
5583.33 ng/mL
Standard Deviation 1146.575
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 17: 3 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
5116.67 ng/mL
Standard Deviation 1608.426
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 17: 4 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
5066.67 ng/mL
Standard Deviation 2009.784
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 17: 6 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
4293.33 ng/mL
Standard Deviation 1654.398
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
|
Plasma Concentration of MLN1117-1003
Day 17: 8 Hours Postdose
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
4330.00 ng/mL
Standard Deviation 2606.971
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
NA ng/mL
Standard Deviation NA
Data was not analyzed at this timepoint.
|
—
|
Adverse Events
MLN1117 300 mg + Alisertib
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
MLN1117 600 mg + Alisertib
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
MLN1117 300 mg + Paclitaxel
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
MLN1117 600 mg + Paclitaxel
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
MLN1117 300 mg + TAK-659
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
MLN1117 200 mg + Docetaxel
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
MLN1117 300 mg + Docetaxel
Serious events: 4 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
MLN1117 300 mg + Alisertib
n=4 participants at risk
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 participants at risk
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 participants at risk
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 participants at risk
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 participants at risk
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 participants at risk
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 participants at risk
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Liver function test increased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
Other adverse events
| Measure |
MLN1117 300 mg + Alisertib
n=4 participants at risk
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 12 cycles).
|
MLN1117 600 mg + Alisertib
n=6 participants at risk
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; 22, 23, and 24) and 4 days off per week and alisertib 40 mg, tablets, orally, twice daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15,16, and 17) and 4 days off per week on Weeks 1-3, and 1 week off in 28-day treatment cycles until PD or unacceptable toxicity (up to 10 cycles).
|
MLN1117 300 mg + Paclitaxel
n=3 participants at risk
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 6 cycles).
|
MLN1117 600 mg + Paclitaxel
n=6 participants at risk
MLN1117 600 mg, tablets, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, 18; 23, 24, and 25) and 4 days off per week and paclitaxel 80 mg/m\^2, infusion, intravenously, once weekly on (Days 1, 8, and 15) and 1 week off, in 28-day treatment cycles until PD or unacceptable toxicity (up to 3 cycles).
|
MLN1117 300 mg + TAK-659
n=7 participants at risk
MLN1117 300 mg, tablets, orally, once daily for 3 days on (Days 1, 2, 3; 8, 9, 10; 15, 16, 17; and 22, 23, and 24) and 4 days off per week and TAK-659 100 mg (as determined in study C34001 \[NCT02000934\]), tablets, orally, once daily, in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity (up to 3 cycles).
|
MLN1117 200 mg + Docetaxel
n=2 participants at risk
MLN1117 200 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 1 cycle).
|
MLN1117 300 mg + Docetaxel
n=4 participants at risk
MLN1117 300 mg, orally, once daily for 3 days on (Days 2, 3, 4; 9, 10, 11; 16, 17, and 18) and 4 days off per week and docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 once every 3 weeks in 21-day treatment cycles until PD or unacceptable toxicity (up to 2 cycles).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
3/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
42.9%
3/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
66.7%
2/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
57.1%
4/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
3/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
57.1%
4/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
66.7%
4/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
66.7%
2/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Gastrointestinal disorders
Oesophagitis
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
57.1%
4/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
66.7%
4/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Fatigue
|
75.0%
3/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
3/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Chills
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
66.7%
2/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Asthenia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Malaise
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Face oedema
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Feeling jittery
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Pain
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
General disorders
Peripheral swelling
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
66.7%
4/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
100.0%
4/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
66.7%
2/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Onychomalacia
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Scab
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
2/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Infections and infestations
Urinary tract infection bacterial
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
3/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
28.6%
2/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
100.0%
2/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
3/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
2/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
42.9%
3/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
42.9%
3/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
14.3%
1/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Product Issues
Device occlusion
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Product Issues
Thrombosis in device
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
50.0%
1/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
16.7%
1/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
33.3%
1/3 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/6 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/7 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
0.00%
0/2 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
25.0%
1/4 • From first dose of study drug through 30 days after the last dose of study drug. Related SAEs could be reported at any time after discontinuation.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Laboratory finding that are considered clinically significant, drive dose modifications or the use of concomitant medications, are considered AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER