Trial Outcomes & Findings for Pharmacokinetic Study of Oral IXAZOMIB in Cancer Patients With Liver Dysfunction (NCT NCT01912222)
NCT ID: NCT01912222
Last Updated: 2016-06-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Results posted on
2016-06-02
Participant Flow
Participants took part in the study at 4 investigative sites in the United States from 27 August 2013 to 25 March 2015.
Participants with diagnosis of advanced solid tumors or hematologic malignancies having varying degrees of liver dysfunction enrolled in 1 of 3 treatment groups to receive ixazomib 4 mg (normal hepatic function), 2.3 mg (moderate impairment), 1.5 mg (severe impairment) on Day 1 (Part A, 15 day cycle) and on Days 1,8 and 15(Part B, 28 day cycle).
Participant milestones
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Part A: Pharmacokinetic Period
STARTED
|
13
|
15
|
20
|
|
Part A: Pharmacokinetic Period
COMPLETED
|
12
|
13
|
18
|
|
Part A: Pharmacokinetic Period
NOT COMPLETED
|
1
|
2
|
2
|
|
Part B: Treatment Period
STARTED
|
13
|
15
|
20
|
|
Part B: Treatment Period
COMPLETED
|
0
|
0
|
0
|
|
Part B: Treatment Period
NOT COMPLETED
|
13
|
15
|
20
|
Reasons for withdrawal
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Part A: Pharmacokinetic Period
Not evaluable for PK analyses
|
1
|
2
|
2
|
|
Part B: Treatment Period
Progressive disease
|
10
|
12
|
15
|
|
Part B: Treatment Period
Adverse Event
|
1
|
2
|
3
|
|
Part B: Treatment Period
Withdrawal by Subject
|
2
|
1
|
2
|
Baseline Characteristics
Pharmacokinetic Study of Oral IXAZOMIB in Cancer Patients With Liver Dysfunction
Baseline characteristics by cohort
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
n=13 Participants
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
n=15 Participants
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
n=20 Participants
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 15.19 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 15.26 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 13.84 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 14.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Height
|
168.6 centimeter (cm)
STANDARD_DEVIATION 6.79 • n=5 Participants
|
168.6 centimeter (cm)
STANDARD_DEVIATION 12.56 • n=7 Participants
|
169.6 centimeter (cm)
STANDARD_DEVIATION 27.54 • n=5 Participants
|
169.0 centimeter (cm)
STANDARD_DEVIATION 19.01 • n=4 Participants
|
|
Weight
|
74.42 kilogram (kg)
STANDARD_DEVIATION 16.788 • n=5 Participants
|
76.97 kilogram (kg)
STANDARD_DEVIATION 12.050 • n=7 Participants
|
76.94 kilogram (kg)
STANDARD_DEVIATION 23.498 • n=5 Participants
|
76.27 kilogram (kg)
STANDARD_DEVIATION 18.431 • n=4 Participants
|
|
Disease type at diagnosis
Solid tumor
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Disease type at diagnosis
Other
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Months from initial diagnosis to first dose of ixazomib
|
56.5 months
STANDARD_DEVIATION 43.40 • n=5 Participants
|
23.7 months
STANDARD_DEVIATION 16.59 • n=7 Participants
|
35.2 months
STANDARD_DEVIATION 28.73 • n=5 Participants
|
37.4 months
STANDARD_DEVIATION 32.56 • n=4 Participants
|
|
Participants with prior antineoplastic therapy
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
20 participants
n=5 Participants
|
48 participants
n=4 Participants
|
|
Participant with prior radiation
Had prior radiation
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Participant with prior radiation
Had no prior radiation
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Participant with prior surgery
Had prior surgery
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Participant with prior surgery
Had no prior surgery
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) performance status
0
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) performance status
1
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
19 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Baseline total bilirubin
|
7.43 micro mole per liter (mcmol/L)
STANDARD_DEVIATION 3.092 • n=5 Participants
|
40.25 micro mole per liter (mcmol/L)
STANDARD_DEVIATION 5.594 • n=7 Participants
|
108.61 micro mole per liter (mcmol/L)
STANDARD_DEVIATION 78.372 • n=5 Participants
|
59.85 micro mole per liter (mcmol/L)
STANDARD_DEVIATION 66.249 • n=4 Participants
|
|
Baseline aspartate aminotransferase (AST)
|
21.04 units per liter (U/L)
STANDARD_DEVIATION 6.884 • n=5 Participants
|
169.97 units per liter (U/L)
STANDARD_DEVIATION 147.433 • n=7 Participants
|
197.48 units per liter (U/L)
STANDARD_DEVIATION 198.211 • n=5 Participants
|
141.09 units per liter (U/L)
STANDARD_DEVIATION 167.256 • n=4 Participants
|
PRIMARY outcome
Timeframe: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dosePopulation: The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.
Outcome measures
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
n=12 Participants
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
n=10 Participants
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
n=11 Participants
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Unbound AUC(0-last): Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib
|
9.6476 nanogram*hours per milliliter (ng*hr/mL)
Standard Deviation 5.39885
|
7.3292 nanogram*hours per milliliter (ng*hr/mL)
Standard Deviation 5.35269
|
4.4383 nanogram*hours per milliliter (ng*hr/mL)
Standard Deviation 4.21266
|
PRIMARY outcome
Timeframe: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dosePopulation: The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.
Outcome measures
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
n=12 Participants
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
n=13 Participants
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
n=18 Participants
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib
|
0.50893 nanogram per milliliter (ng/mL)
Standard Deviation 0.271928
|
0.37245 nanogram per milliliter (ng/mL)
Standard Deviation 0.385113
|
0.23176 nanogram per milliliter (ng/mL)
Standard Deviation 0.271358
|
PRIMARY outcome
Timeframe: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dosePopulation: The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.
Outcome measures
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
n=12 Participants
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
n=13 Participants
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
n=18 Participants
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
|
0.950 hours
Interval 0.48 to 4.0
|
1.500 hours
Interval 0.5 to 2.5
|
1.205 hours
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles])Population: The safety analysis population was defined as participants who received at least 1 dose of ixazomib.
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. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
n=13 Participants
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
n=15 Participants
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
n=20 Participants
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
TEAE
|
13 participants
|
15 participants
|
20 participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
SAE
|
6 participants
|
10 participants
|
15 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)Population: The safety analysis population was defined as participants who received at least 1 dose of ixazomib.
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Outcome measures
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
n=13 Participants
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
n=15 Participants
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
n=20 Participants
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)Population: The safety analysis population was defined as participants who received at least 1 dose of ixazomib.
Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).
Outcome measures
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
n=13 Participants
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
n=15 Participants
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
n=20 Participants
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Normal Hepatic Function (Ixazomib 4 mg)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Severe Hepatic Impairment (Ixazomib 1.5 mg)
Serious events: 15 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
n=13 participants at risk
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
n=15 participants at risk
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
n=20 participants at risk
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
6/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Axillary pain
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pain
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Device related infection
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Confusional state
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Superior vena cava syndrome
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Normal Hepatic Function (Ixazomib 4 mg)
n=13 participants at risk
Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
|
Moderate Hepatic Impairment (Ixazomib 2.3 mg)
n=15 participants at risk
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
|
Severe Hepatic Impairment (Ixazomib 1.5 mg)
n=20 participants at risk
Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.4%
2/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
3/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
23.1%
3/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral candidiasis
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bacteraemia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
23.1%
3/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Peroneal nerve palsy
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Ammonia increased
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood urea increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Waist circumference increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
15.4%
2/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
53.8%
7/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.4%
2/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
15.4%
2/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
4/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
15.4%
2/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Early satiety
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiomegaly
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Photopsia
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
7.7%
1/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
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