Trial Outcomes & Findings for Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment (NCT NCT01830816)
NCT ID: NCT01830816
Last Updated: 2019-06-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose
Results posted on
2019-06-10
Participant Flow
Participants took part in the study at 6 investigative sites in the United States and Canada from 16 September 2013 up to 18 November 2016.
Participants with a diagnosis of relapsed or refractory multiple myeloma (RRMM) or advanced solid tumors who had normal renal function or severe renal impairment including end-stage renal disease requiring hemodialysis (ESRD) were enrolled to receive ixazomib orally in the study.
Participant milestones
| Measure |
Normal Renal Function: Ixazomib
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Severe Renal Impairment: Ixazomib
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
End-stage Renal Disease: Ixazomib
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
14
|
7
|
|
Overall Study
Pharmacokinetic-Evaluable Population
|
18
|
14
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
14
|
7
|
Reasons for withdrawal
| Measure |
Normal Renal Function: Ixazomib
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Severe Renal Impairment: Ixazomib
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
End-stage Renal Disease: Ixazomib
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Progressive Disease
|
12
|
7
|
7
|
|
Overall Study
Adverse Event
|
3
|
4
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Symptomatic Deterioration
|
1
|
0
|
0
|
|
Overall Study
Reason not Specified
|
2
|
0
|
0
|
Baseline Characteristics
Number analyzed is the number of participants with data available for height.
Baseline characteristics by cohort
| Measure |
Normal Renal Function: Ixazomib
n=20 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Severe Renal Impairment: Ixazomib
n=14 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
End-stage Renal Disease: Ixazomib
n=7 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 9.01 • n=20 Participants
|
72.1 years
STANDARD_DEVIATION 7.35 • n=14 Participants
|
61.3 years
STANDARD_DEVIATION 12.65 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 12.01 • n=41 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
12 Participants
n=14 Participants
|
3 Participants
n=7 Participants
|
25 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=20 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
19 Participants
n=20 Participants
|
10 Participants
n=14 Participants
|
6 Participants
n=7 Participants
|
35 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=20 Participants
|
11 Participants
n=14 Participants
|
3 Participants
n=7 Participants
|
27 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=20 Participants
|
3 Participants
n=14 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=41 Participants
|
|
Height
|
173.2 cm
STANDARD_DEVIATION 11.28 • n=20 Participants • Number analyzed is the number of participants with data available for height.
|
160.8 cm
STANDARD_DEVIATION 8.49 • n=14 Participants • Number analyzed is the number of participants with data available for height.
|
160.3 cm
STANDARD_DEVIATION 9.61 • n=5 Participants • Number analyzed is the number of participants with data available for height.
|
167.1 cm
STANDARD_DEVIATION 11.76 • n=39 Participants • Number analyzed is the number of participants with data available for height.
|
|
Weight
|
98.1 kg
STANDARD_DEVIATION 27.66 • n=20 Participants
|
60.7 kg
STANDARD_DEVIATION 14.70 • n=14 Participants
|
86.0 kg
STANDARD_DEVIATION 27.11 • n=7 Participants
|
83.3 kg
STANDARD_DEVIATION 28.85 • n=41 Participants
|
PRIMARY outcome
Timeframe: Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dosePopulation: Pharmacokinetic (PK) evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.
Outcome measures
| Measure |
Normal Renal Function: Ixazomib
n=18 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Severe Renal Impairment: Ixazomib
n=14 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
End-stage Renal Disease: Ixazomib
n=6 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib
|
0.300 ng/mL
Standard Deviation 0.247944
|
0.478 ng/mL
Standard Deviation 0.599519
|
0.213 ng/mL
Standard Deviation 0.136696
|
PRIMARY outcome
Timeframe: Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dosePopulation: PK evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.
Outcome measures
| Measure |
Normal Renal Function: Ixazomib
n=18 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Severe Renal Impairment: Ixazomib
n=14 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
End-stage Renal Disease: Ixazomib
n=6 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
|
1.0400 hours
Interval 0.467 to 4.0
|
1.0000 hours
Interval 0.45 to 1.5
|
1.2500 hours
Interval 0.983 to 7.0
|
PRIMARY outcome
Timeframe: Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dosePopulation: PK evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.
Outcome measures
| Measure |
Normal Renal Function: Ixazomib
n=15 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Severe Renal Impairment: Ixazomib
n=10 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
End-stage Renal Disease: Ixazomib
n=6 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Unbound AUClast: Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib
|
6.637 hr*ng/mL
Standard Deviation 4.8022
|
9.249 hr*ng/mL
Standard Deviation 6.2618
|
8.925 hr*ng/mL
Standard Deviation 5.7995
|
SECONDARY outcome
Timeframe: From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)Population: Safety population is defined as participants who received at least 1 dose of study drug.
Adverse Event 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 Renal Function: Ixazomib
n=20 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Severe Renal Impairment: Ixazomib
n=14 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
End-stage Renal Disease: Ixazomib
n=7 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
19 participants
|
14 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)Population: Response evaluable is defined as participants who received at least 1 cycle of ixazomib treatment in Part B and at least 1 post-baseline response assessment.
Overall response rate defined as percentage of relapsed/refractory multiple myeloma participants who achieved partial response (PR), complete response (CR) and very good partial response (VGPR) according to International Myeloma Working Group Criteria. PR=\>50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or \<200 mg/24 h. If serum and urine M-protein are unmeasurable, \>50% decrease in difference between involved and uninvolved free light chain levels in place of M-protein criteria. If serum and urine M-protein and serum free light assay are not measurable, \>50% reduction in plasma cells in place of M-protein, provided baseline bone marrow plasma cell \>0%; CR=negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 h.
Outcome measures
| Measure |
Normal Renal Function: Ixazomib
n=14 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Severe Renal Impairment: Ixazomib
n=11 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
End-stage Renal Disease: Ixazomib
n=4 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Percentage of Participants With Overall Response (OR) in Relapsed/Refractory Multiple Myeloma (RRMM) Participants
|
29 percentage of participants
Interval 8.0 to 58.0
|
18 percentage of participants
Interval 2.0 to 52.0
|
0 percentage of participants
No participant had overall response.
|
SECONDARY outcome
Timeframe: Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)Population: Response evaluable population is defined as participants who received at least 1 cycle of Ixazomib treatment in Part B and at least 1 post-baseline response assessment. Here, number of participants analyzed is the participants who had confirmed response.
DOR was defined as time from date of first documentation of a PR or better to date of first documentation of progressive disease (PD) for responders. Increase of \>25% from lowest response value in any one or more of following: Serum M-component and/or (absolute increase must be \>0.5 g/dL); Urine M-component and/or (the absolute increase must be \>200 mg/24 h); difference between involved and uninvolved free light chain (FLC) levels and the absolute increase must be \> 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage must be \> 5%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Responders without PD were censored at the date of the last response assessment that was stable disease (SD) or better.
Outcome measures
| Measure |
Normal Renal Function: Ixazomib
n=4 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
Severe Renal Impairment: Ixazomib
n=2 Participants
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
End-stage Renal Disease: Ixazomib
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Duration of Response (DOR) in RRMM Participants
|
134 days
Interval 72.0 to 233.0
|
225 days
Interval 225.0 to 225.0
|
—
|
Adverse Events
Normal Renal Function: Ixazomib
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Severe Renal Impairment: Ixazomib
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
End-stage Renal Disease: Ixazomib
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal Renal Function: Ixazomib
n=20 participants at risk
Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in normal renal function participants until disease progression or unacceptable toxicity in part B.
Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
|
Severe Renal Impairment: Ixazomib
n=14 participants at risk
Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in severe renal impairment participants until disease progression or unacceptable toxicity in part B.
Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
|
End-stage Renal Disease: Ixazomib
n=7 participants at risk
Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in end-stage renal disease participants until disease progression or unacceptable toxicity in part B.
Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Sepsis
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Pancreatitis acute
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Gastrointestinal haemorrhage
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Skin infection
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Hypoglycaemia
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Respiratory failure
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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)
Gastrooesophageal cancer
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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)
Plasma cell myeloma
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Acute kidney injury
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Diverticulitis
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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 Renal Function: Ixazomib
n=20 participants at risk
Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in normal renal function participants until disease progression or unacceptable toxicity in part B.
Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
|
Severe Renal Impairment: Ixazomib
n=14 participants at risk
Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in severe renal impairment participants until disease progression or unacceptable toxicity in part B.
Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
|
End-stage Renal Disease: Ixazomib
n=7 participants at risk
Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in end-stage renal disease participants until disease progression or unacceptable toxicity in part B.
Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
8/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
6/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
35.0%
7/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
35.7%
5/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
30.0%
6/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
35.7%
5/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
30.0%
6/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.4%
3/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
15.0%
3/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
15.0%
3/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Gastrooesophageal reflux disease
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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 discomfort
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Dysphagia
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Gastritis
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
25.0%
5/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
6/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Oedema peripheral
|
10.0%
2/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
4/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
2/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Chest discomfort
|
10.0%
2/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Influenza like illness
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Peripheral swelling
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
15.0%
3/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Hypocalcaemia
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
4/14 • Number of events 4 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
20.0%
4/20 • Number of events 6 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Peripheral sensory neuropathy
|
10.0%
2/20 • Number of events 4 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Number of events 3 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
2/20 • Number of events 3 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Arthralgia
|
15.0%
3/20 • Number of events 3 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Number of events 4 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Muscle spasms
|
5.0%
1/20 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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 pain
|
5.0%
1/20 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Bone pain
|
10.0%
2/20 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Joint swelling
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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 jaw
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.4%
3/14 • Number of events 4 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
2/20 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Oropharyngeal pain
|
10.0%
2/20 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Hiccups
|
10.0%
2/20 • Number of events 4 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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 exertional
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Epistaxis
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Pneumonia aspiration
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Respiratory failure
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Rhinorrhoea
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Sinus congestion
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Upper-airway cough syndrome
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
15.0%
3/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.4%
3/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Platelet count decreased
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.4%
3/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
2/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Neutrophil count decreased
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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 decreased
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Creatinine renal clearance increased
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
2/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
35.7%
5/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Neutropenia
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Upper respiratory tract infection
|
25.0%
5/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.4%
3/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Fungal skin infection
|
10.0%
2/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Herpes virus infection
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Parainfluenzae virus infection
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
2/20 • Number of events 3 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Urticaria
|
10.0%
2/20 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Dry skin
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Erythema multiforme
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
2/20 • Number of events 3 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
2/20 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Mood altered
|
10.0%
2/20 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
|
5.0%
1/20 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Hypertension
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Number of events 2 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Cataract
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Eye pain
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Vision blurred
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Ear pain
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Middle ear effusion
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Contusion
|
5.0%
1/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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 disorders
|
10.0%
2/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/14 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Micturition urgency
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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
Pollakiuria
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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)
Benign renal neoplasm
|
0.00%
0/20 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Number of events 1 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
At each visit the investigator had to document any occurrence of adverse events and 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