Trial Outcomes & Findings for Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) (NCT NCT01179737)
NCT ID: NCT01179737
Last Updated: 2014-05-01
Results Overview
Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Study was prematurely terminated and not powered for efficacy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
168 days
Results posted on
2014-05-01
Participant Flow
23 participants were enrolled into the study (15 in cohort 1; 8 in cohort 2) 8 participants completed cohort 1 and 6 of these participants moved into cohort 1expansion. Of the 5 participants that completed Cohort 1 expansion; 3 participants went into an Extension. None of the participants completed treatment as trial was terminated
Participants were randomized 6:1 ratio to nilotinib and placebo
Participant milestones
| Measure |
Cohort 1: Nilotinib
Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
|
Cohort 1: Placebo
Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
|
Cohort 2: Nilotinib
Participants were assigned to receive nilotinib 300 mg during 168 days
|
Cohort 2: Placebo
Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
|
|---|---|---|---|---|
|
Cohort 1 & Cohort 2
STARTED
|
12
|
3
|
4
|
4
|
|
Cohort 1 & Cohort 2
COMPLETED
|
7
|
1
|
0
|
0
|
|
Cohort 1 & Cohort 2
NOT COMPLETED
|
5
|
2
|
4
|
4
|
|
Cohort 1 & Cohort 2 Expansion
STARTED
|
5
|
1
|
0
|
0
|
|
Cohort 1 & Cohort 2 Expansion
COMPLETED
|
4
|
1
|
0
|
0
|
|
Cohort 1 & Cohort 2 Expansion
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Extension
STARTED
|
3
|
0
|
0
|
0
|
|
Extension
COMPLETED
|
0
|
0
|
0
|
0
|
|
Extension
NOT COMPLETED
|
3
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Nilotinib
Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
|
Cohort 1: Placebo
Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
|
Cohort 2: Nilotinib
Participants were assigned to receive nilotinib 300 mg during 168 days
|
Cohort 2: Placebo
Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
|
|---|---|---|---|---|
|
Cohort 1 & Cohort 2
Adverse Event
|
3
|
1
|
1
|
0
|
|
Cohort 1 & Cohort 2
Withdrew consent
|
2
|
0
|
0
|
0
|
|
Cohort 1 & Cohort 2
Administrative problems
|
0
|
0
|
2
|
4
|
|
Cohort 1 & Cohort 2
Death
|
0
|
0
|
1
|
0
|
|
Cohort 1 & Cohort 2
Withdrew consent without EOS 1 visit
|
0
|
1
|
0
|
0
|
|
Cohort 1 & Cohort 2 Expansion
Death
|
1
|
0
|
0
|
0
|
|
Extension
The study was terminated
|
3
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)
Baseline characteristics by cohort
| Measure |
Cohort 1: Nilotinib
n=12 Participants
Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
|
Cohort 1: Placebo
n=3 Participants
Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
|
Cohort 2: Nilotinib
n=4 Participants
Participants were assigned to receive nilotinib 300 mg during 168 days
|
Cohort 2: Placebo
n=4 Participants
Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
60 Years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
31 Years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
33 Years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
32 Years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 168 daysChange in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Study was prematurely terminated and not powered for efficacy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 168 daysDuring standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. Study was prematurely terminated and efficacy data were not analyzed or summarized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 168 daysAdverse events were summarized by the number of patients having any adverse event overall and presented in the safety section. Study was prematurely terminated.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Nilotinib
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Nilotinib
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Nilotinib
n=12 participants at risk
Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
|
Cohort 1: Placebo
n=3 participants at risk
Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
|
Cohort 2: Nilotinib
n=4 participants at risk
Participants were assigned to receive nilotinib 300 mg during 168 days
|
Cohort 2: Placebo
n=4 participants at risk
Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Chronic hepatitis
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Lobar pneumonia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Vascular disorders
Thrombophlebitis superficial
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Pulseless electrical activity
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Right ventricular dysfunction
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Chest pain
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Device leakage
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Hepatobiliary disorders
Cholecystitis acute
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Hepatobiliary disorders
Cholelithiasis
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
Other adverse events
| Measure |
Cohort 1: Nilotinib
n=12 participants at risk
Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
|
Cohort 1: Placebo
n=3 participants at risk
Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
|
Cohort 2: Nilotinib
n=4 participants at risk
Participants were assigned to receive nilotinib 300 mg during 168 days
|
Cohort 2: Placebo
n=4 participants at risk
Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Blood and lymphatic system disorders
Bone marrow oedema
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Blood and lymphatic system disorders
Pancytopenia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Blood and lymphatic system disorders
Polychromasia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Blood and lymphatic system disorders
Red blood cell abnormality
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Dilatation ventricular
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Left atrial dilatation
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Palpitations
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Right ventricular failure
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Right ventricular hypertrophy
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Tricuspid valve incompetence
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Ventricular extrasystoles
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Cardiac disorders
Ventricular tachycardia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Eye disorders
Eye pain
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
4/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Mucous stools
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
75.0%
3/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
75.0%
3/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Application site irritation
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Asthenia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Catheter site inflammation
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Chest discomfort
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Chest pain
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Chills
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Fatigue
|
50.0%
6/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Injection site pain
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Oedema
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Oedema peripheral
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Pain
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
General disorders
Pyrexia
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Candidiasis
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Device related infection
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Urinary tract infection fungal
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Viral sinusitis
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Infections and infestations
Wound infection staphylococcal
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Amylase increased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Biopsy bone
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
50.0%
2/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Blood calcium decreased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Blood potassium decreased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Blood triglycerides increased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Blood uric acid increased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
C-reactive protein increased
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Electrocardiogram T wave inversion
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Eosinophil count increased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Haematocrit decreased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Haemoglobin decreased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Heart rate increased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Lipase increased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Liver function test abnormal
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Lymphocyte count decreased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Reproductive system and breast disorders
Gynaecomastia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Platelet count increased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Red blood cell burr cells present
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Red blood cell count decreased
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Right ventricular systolic pressure increased
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
Weight decreased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Investigations
White blood cell count decreased
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Metabolism and nutrition disorders
Fluid retention
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Nervous system disorders
Carpal tunnel syndrome
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Nervous system disorders
Convulsion
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Nervous system disorders
Headache
|
50.0%
6/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
75.0%
3/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Nervous system disorders
Migraine
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
50.0%
2/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Psychiatric disorders
Decreased interest
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Renal and urinary disorders
Renal failure acute
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
4/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmalgia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
33.3%
1/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
3/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
50.0%
2/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Vascular disorders
Flushing
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
25.0%
1/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
|
Vascular disorders
Inferior vena cava dilatation
|
16.7%
2/12 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/3 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
0.00%
0/4 • Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER