Trial Outcomes & Findings for Phase 1 Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C (NCT NCT01577758)
NCT ID: NCT01577758
Last Updated: 2016-09-07
Results Overview
DLT was defined as any of the following Adverse Events (AEs) that occur and are considered by the investigator to be related to therapy. 1. Grade 4 neutropenia (Absolute Neutrophil Count \< 500 cells/mm\^3). 2. Grade 3 or greater neutropenia with fever and/or infection. 3. Grade 4 thrombocytopenia (platelets \< 25,000/mm\^3). 4. Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time. 5. Grade 3 or greater nausea and/or emesis that occurs despite of prophylaxis. 6. Grade 3 or greater diarrhea that occurs despite supportive care. 7. Any other Grade 3 or greater non-hematological toxicity other than Grade 3 fatigue or Grade 3 Alopecia. 8. Inability to start the next cycle of therapy due to treatment delay of more than 2 weeks because of lack of recovery. 9. Other MLN0264-related non-hematologic toxicities Grade 2 or greater requiring discontinuation of therapy.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months
Results posted on
2016-09-07
Participant Flow
Participants took part in the study at 4 investigative sites in the United States and Spain from 11 June 2012 to 12 February 2014.
Participants with Gastrointestinal malignancies expressing guanylyl cyclase C were enrolled in the dose escalation phase: 0.3, 0.6, 1.2, 1.5, 1.8, 2.1 and 2.4 mg/kg to determine the maximum tolerated dose (MTD). MTD was established and participants were enrolled in the mCRC expansion phase. 3 participants were in both the 1.8 mg/kg and mCRC arms.
Participant milestones
| Measure |
MLN0264 0.3 mg/kg
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase
STARTED
|
2
|
2
|
2
|
2
|
6
|
4
|
1
|
0
|
|
Dose Escalation Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
NOT COMPLETED
|
2
|
2
|
2
|
2
|
6
|
4
|
1
|
0
|
|
mCRC Expansion Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
25
|
|
mCRC Expansion Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
mCRC Expansion Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
25
|
Reasons for withdrawal
| Measure |
MLN0264 0.3 mg/kg
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Dose Escalation Phase
Symptomatic Deterioration
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Dose Escalation Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Escalation Phase
Progression Disease
|
2
|
2
|
1
|
2
|
5
|
0
|
0
|
0
|
|
mCRC Expansion Phase
Symptomatic Deterioration
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
|
mCRC Expansion Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
mCRC Expansion Phase
Progression Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
Baseline Characteristics
Phase 1 Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C
Baseline characteristics by cohort
| Measure |
All Participants
n=41 Participants
All participants who participated in the Dose Escalation and mCRC Expansion Phases.
|
|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 10.81 • n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
34 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
39 participants
n=99 Participants
|
|
Height
|
170.4 cm
STANDARD_DEVIATION 7.69 • n=99 Participants
|
|
Weight
|
78.50 kg
STANDARD_DEVIATION 18.573 • n=99 Participants
|
|
Body Surface Area
|
1.929 m^2
STANDARD_DEVIATION 0.2424 • n=99 Participants
|
PRIMARY outcome
Timeframe: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 monthsPopulation: DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.
DLT was defined as any of the following Adverse Events (AEs) that occur and are considered by the investigator to be related to therapy. 1. Grade 4 neutropenia (Absolute Neutrophil Count \< 500 cells/mm\^3). 2. Grade 3 or greater neutropenia with fever and/or infection. 3. Grade 4 thrombocytopenia (platelets \< 25,000/mm\^3). 4. Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time. 5. Grade 3 or greater nausea and/or emesis that occurs despite of prophylaxis. 6. Grade 3 or greater diarrhea that occurs despite supportive care. 7. Any other Grade 3 or greater non-hematological toxicity other than Grade 3 fatigue or Grade 3 Alopecia. 8. Inability to start the next cycle of therapy due to treatment delay of more than 2 weeks because of lack of recovery. 9. Other MLN0264-related non-hematologic toxicities Grade 2 or greater requiring discontinuation of therapy.
Outcome measures
| Measure |
MLN0264 0.3 mg/kg
n=2 Participants
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
n=2 Participants
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
n=2 Participants
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
n=2 Participants
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
n=6 Participants
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
n=4 Participants
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
n=1 Participants
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 monthsPopulation: Safety Analysis Set included all participants who received at least one dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
MLN0264 0.3 mg/kg
n=19 Participants
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
n=25 Participants
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Adverse Events
|
19 participants
|
25 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Serious Adverse Events
|
8 participants
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 3 weeks until MTD is established, approximately 9 monthsPopulation: DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.
MTD of MLN0264 was determined. Decisions regarding dose escalation were made based on any DLT that occurred during the first cycle of treatment.
Outcome measures
| Measure |
MLN0264 0.3 mg/kg
n=19 Participants
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of MLN0264
|
1.8 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1: Day 1 pre-dose to Day 21 post-dosePopulation: Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.
Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.
Outcome measures
| Measure |
MLN0264 0.3 mg/kg
n=28 Participants
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Serum Concentration for MLN0264
|
48.63 μg/mL
Interval 34.1 to 85.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1: Day 1 pre-dose to Day 21 post-dosePopulation: Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.
Outcome measures
| Measure |
MLN0264 0.3 mg/kg
n=28 Participants
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)
|
7.91 ng/mL
Interval 4.02 to 18.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1: Day 1 pre-dose to 21 Days post-dosePopulation: Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.
Area under the drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.
Outcome measures
| Measure |
MLN0264 0.3 mg/kg
n=28 Participants
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MLN0246
|
67.81 day*μg/mL
Interval 44.5 to 118.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1: Day 1 pre-dose to 21 Days post-dosePopulation: Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameter AUC0-21 days.
Area under the plasma drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.
Outcome measures
| Measure |
MLN0264 0.3 mg/kg
n=26 Participants
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MMAE
|
51.90 day*ng/mL
Interval 24.5 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the completion of every second cycle up to 12 cycles (approximately 9 months). Each cycle is a 21 days cyclePopulation: Response Evaluable Population is defined as patients with measureable disease who receive any amount of MLN0264 and have at least 1 post-Baseline response assessment.
The percentage of participants in each best overall response category, was determined using the Modified Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response: Disappearance of all target lesions and all non-target lesions and normalization of tumor marker level. Partial Response: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the start or the appearance of one or more new lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
MLN0264 0.3 mg/kg
n=18 Participants
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
n=24 Participants
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
Best Overall Response
Partial Response (PR)
|
6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response
Complete Response (CR)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response
CR + PR
|
6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response
Stable Disease
|
39 percentage of participants
|
42 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response
Progressive Disease
|
56 percentage of participants
|
58 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of every 21 days cycle and at End of study (EOS) approximately 9 monthsBlood was collected and sent to a laboratory to determine the immunogenicity, whether binding antibodies to MLN0264 were present (ATA development).
Outcome measures
| Measure |
MLN0264 0.3 mg/kg
n=2 Participants
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
n=2 Participants
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
n=2 Participants
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
n=2 Participants
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
n=6 Participants
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
n=4 Participants
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
n=1 Participants
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg (mCRC Expansion)
n=25 Participants
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
MLN0264 0.3 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MLN0264 0.6 mg/kg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
MLN0264 1.2 mg/kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
MLN0264 1.5 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MLN0264 1.8 mg/kg
Serious events: 10 serious events
Other events: 28 other events
Deaths: 0 deaths
MLN0264 2.1 mg/kg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
MLN0264 2.4 mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MLN0264 0.3 mg/kg
n=2 participants at risk
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
n=2 participants at risk
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
n=2 participants at risk
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
n=2 participants at risk
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
n=28 participants at risk
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
n=4 participants at risk
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
n=1 participants at risk
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Febrile neutropenia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.7%
3/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Supraventricular tachycardia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Colonic obstruction
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Small intestinal obstruction
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Psoas abscess
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Electrocardiogram QT prolonged
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Troponin T increased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Acidosis
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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)
Oesophageal carcinoma
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Convulsion
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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 |
MLN0264 0.3 mg/kg
n=2 participants at risk
MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 0.6 mg/kg
n=2 participants at risk
MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.2 mg/kg
n=2 participants at risk
MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.5 mg/kg
n=2 participants at risk
MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 1.8 mg/kg
n=28 participants at risk
MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.1 mg/kg
n=4 participants at risk
MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
MLN0264 2.4 mg/kg
n=1 participants at risk
MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
10/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
7/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
75.0%
3/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
17.9%
5/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Tachycardia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Periorbital oedema
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
7/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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 lower
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
8/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
10/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
53.6%
15/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
75.0%
3/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Oral pain
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
7/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
10/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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 pain
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
46.4%
13/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pain
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
10/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Nasopharyngitis
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Pharyngitis
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
6/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
8/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.7%
3/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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 bilirubin increased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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 magnesium decreased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Carbon dioxide increased
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Electrocardiogram QT prolonged
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.7%
3/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Gamma-glutamyltransferase increased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Liver function test abnormal
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Lymphocyte count decreased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Mean cell haemoglobin concentration decreased
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Mean cell volume decreased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Monocyte count decreased
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Monocyte count increased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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 increased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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 increased
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Transaminases increased
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
White blood cell count increased
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
60.7%
17/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
100.0%
2/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Hypoalbuminaemia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
17.9%
5/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.7%
3/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.7%
3/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Syncope
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
17.9%
5/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Dysuria
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Hydronephrosis
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.7%
3/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Alopecia
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
32.1%
9/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Dermatitis allergic
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Hyperhidrosis
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
Nail disorder
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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 erythematous
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/28 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/4 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/1 • From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months)
At each visit the investigator had to document any occurrence of adverse events and 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 Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER