Trial Outcomes & Findings for A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015) (NCT NCT00963547)
NCT ID: NCT00963547
Last Updated: 2024-06-04
Results Overview
The number of participants experiencing an adverse event (AE) was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Further, any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Up to 36 weeks (up to 4 weeks following cessation of study treatment)
Results posted on
2024-06-04
Participant Flow
Per protocol, this trial was to be conducted in 2 parts. In Part 1 (Pt. 1), 33 participants were enrolled, with 31 participants receiving study treatment. Due to trial termination, enrollment into the study was discontinued and Part 2 (Pt. 2) did not begin.
Participant milestones
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
Participants in Part 1 (Pt. 1) receive MK-2206 45 mg every other day (QOD), taken orally. In combination with MK-2206, trastuzumab is administered by intravenous (IV) infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg every 3 weeks (q3wk).
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
Participants in Pt. 1 receive MK-2206 135 mg once weekly (QW), taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib 500mg, QD
Participants in Part 2 (Pt. 2) receive MK-2206 (dosed either QOD or QW) taken orally at the maximum tolerated dose defined in Part 1 (Pt. 1 MTD). MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib 500 mg taken orally once daily (QD).
|
Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib 750mg, QD
Participants in Pt. 2 receive MK-2206 (dosed either QOD or QW) taken orally at the Pt. 1 MTD. MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib 750 mg taken orally QD.
|
Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib 1000mg, QD
Participants in Pt. 2 receive MK-2206 (dosed either QOD or QW) taken orally at the Pt. 1 MTD. MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib 1000 mg taken orally QD.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
11
|
12
|
6
|
0
|
0
|
0
|
|
Overall Study
Treated
|
3
|
11
|
11
|
6
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
11
|
12
|
6
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
Participants in Part 1 (Pt. 1) receive MK-2206 45 mg every other day (QOD), taken orally. In combination with MK-2206, trastuzumab is administered by intravenous (IV) infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg every 3 weeks (q3wk).
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
Participants in Pt. 1 receive MK-2206 135 mg once weekly (QW), taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib 500mg, QD
Participants in Part 2 (Pt. 2) receive MK-2206 (dosed either QOD or QW) taken orally at the maximum tolerated dose defined in Part 1 (Pt. 1 MTD). MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib 500 mg taken orally once daily (QD).
|
Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib 750mg, QD
Participants in Pt. 2 receive MK-2206 (dosed either QOD or QW) taken orally at the Pt. 1 MTD. MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib 750 mg taken orally QD.
|
Pt. 2: MK-2206 (Pt.1 MTD) + Trastuzumab + Lapatinib 1000mg, QD
Participants in Pt. 2 receive MK-2206 (dosed either QOD or QW) taken orally at the Pt. 1 MTD. MK-2206 is administered in combination with trastuzumab (IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk) as well as lapatinib 1000 mg taken orally QD.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
3
|
8
|
9
|
5
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason Unknown
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015)
Baseline characteristics by cohort
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
n=3 Participants
Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
n=11 Participants
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
n=11 Participants
Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
n=6 Participants
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.0 Years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
55.2 Years
STANDARD_DEVIATION 6.9 • n=107 Participants
|
49.6 Years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
49.7 Years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
51.2 Years
STANDARD_DEVIATION 7.7 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 36 weeks (up to 4 weeks following cessation of study treatment)Population: All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; Part 2-specific arms are not included for analysis.
The number of participants experiencing an adverse event (AE) was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Further, any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.
Outcome measures
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
n=3 Participants
Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
n=11 Participants
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
n=11 Participants
Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
n=6 Participants
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
|---|---|---|---|---|
|
Number of Participants Experiencing ≥1 Adverse Event
|
3 Participants
|
11 Participants
|
11 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 32 weeksPopulation: All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; Part 2-specific arms are not included for analysis.
The number of participants discontinuing study drug due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Further, any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.
Outcome measures
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
n=3 Participants
Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
n=11 Participants
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
n=11 Participants
Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
n=6 Participants
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
|---|---|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to an Adverse Event
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeks (up to day 21 of cycle 1)Population: All participants in Part 1 receiving ≥1 dose of study drug were included: 1) if experiencing a DLT in cycle 1; or 2) if not experiencing a DLT in cycle 1, received 90% of planned doses and completed all safety evaluations by ≤20 days after first dose of MK-2206. Trial terminated before Part 2 enrollment; Part 2-specific arms excluded.
A DLT is a drug-related AE not related to disease progression or intercurrent illnesses. Toxicities are graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) version 3.0. The following are considered DLTs: A.) Hematologic \[grade 4 neutropenia (≥5 days); grade 3/4 neutropenia; grade 4 thrombocytopenia.\] B.) Non-Hematologic \[any grade ≥3 non-hematologic toxicity except: grade 3 nausea, vomiting, diarrhea, or dehydration; asthenia; hypersensitivity; grade 3 elevated transaminases (1 week).\] C.) Additional \[any drug-related AE leading to MK-2206 dose modification; grade ≥2 drug-related AE causing drug interruption (≥8 days); any drug-related AE causing drug interruption (≥15 days); grade ≥3 glucose intolerance with grade ≥2 hyperglycemia; fasting glucose \>250 mg/dL (≥2 days); grade ≥3 electrolyte abnormality; lactoacidosis or ketoacidosis; non-fasting grade 4 hyperglycemia; increased QTc interval; significant bradycardia.\].
Outcome measures
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
n=3 Participants
Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
n=11 Participants
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
n=11 Participants
Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
n=6 Participants
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
|---|---|---|---|---|
|
Number of Participants Experiencing ≥1 Dose-Limiting Toxicity (DLT) in Cycle 1
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeks (up to day 21 of cycle 1)Population: All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated), categorized by QOD or QW dosing of MK-2206. Due to trial termination, participants were not enrolled in Part 2; MTD could not be calculated for Part 2.
The maximum tolerated dose (MTD) of MK-2206 in combination with trastuzumab (Part 1) was assessed for both QOD and QW dosing schedules. To calculate MTD, a dose-response curve for the rate of patients in each treatment combination arm experiencing a DLT in Cycle 1 will be estimated using the pooling-of-adjacent-violators algorithm, with this dose-response curve used to determine the MTD. The MTD is defined as the dose at which the percentage of patients experiencing a DLT is the closest to 25% or 30% in Part 1 and Part 2, respectively. As the study was terminated prior to Part 2 enrollment, the MTD of MK-2206 in combination with trastuzumab/lapatinib could not be determined.
Outcome measures
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
n=14 Participants
Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
n=17 Participants
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose of MK-2206 in Combination With Trastuzumab (Part 1) and With Trastuzumab/Lapatinib (Part 2)
|
60 mg
|
200 mg
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 36 weeks (up to 4 weeks following cessation of study treatment)Population: All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated), categorized by QOD or QW dosing of MK-2206. Due to trial termination, participants were not enrolled in Part 2; RP2D could not be calculated for Part 2.
The recommended phase 2 dose (RP2D) of MK-2206 in combination with trastuzumab (Part 1) was assessed. Data from Part 1 informing the determination of the MTD (i.e. DLTs in cycle 1), along with safety and tolerability data, and the pharmacokinetic profile was used to determine the RP2D for both the QOD and QW dosing of MK-2206 in combination with trastuzumab. As the study was terminated prior to Part 2 enrollment, the RP2D of MK-2206 in combination with trastuzumab/lapatinib could not be determined.
Outcome measures
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
n=14 Participants
Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
n=17 Participants
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
|---|---|---|---|---|
|
Recommended Phase 2 Dose of MK-2206 in Combination With Trastuzumab (Part 1) and With Trastuzumab/Lapatinib (Part 2)
|
60 mg
|
135 mg
|
—
|
—
|
Adverse Events
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
Serious events: 5 serious events
Other events: 11 other events
Deaths: 1 deaths
Pt. 1: MK-2206 135mg, QW + Trastuzumab
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Pt. 1: MK-2206 200mg, QW + Trastuzumab
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
n=3 participants at risk
Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
n=11 participants at risk
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
n=11 participants at risk
Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
n=6 participants at risk
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
Other adverse events
| Measure |
Pt. 1: MK-2206 45mg, QOD + Trastuzumab
n=3 participants at risk
Participants in Pt. 1 receive MK-2206 45 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 60mg, QOD + Trastuzumab
n=11 participants at risk
Participants in Pt. 1 receive MK-2206 60 mg QOD, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 135mg, QW + Trastuzumab
n=11 participants at risk
Participants in Pt. 1 receive MK-2206 135 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
Pt. 1: MK-2206 200mg, QW + Trastuzumab
n=6 participants at risk
Participants in Pt. 1 receive MK-2206 200 mg QW, taken orally. In combination with MK-2206, trastuzumab is administered by IV infusion at an initial dose of 8 mg/kg (loading dose) followed by 6 mg/kg q3wk.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
33.3%
2/6 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
50.0%
3/6 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Eye disorders
Retinal tear
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Eye disorders
Vitreous floaters
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Cheilosis
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
45.5%
5/11 • Number of events 5 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 7 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
50.0%
3/6 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 5 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
45.5%
5/11 • Number of events 7 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
50.0%
3/6 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
General disorders
Cyst
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
81.8%
9/11 • Number of events 10 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
54.5%
6/11 • Number of events 11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
83.3%
5/6 • Number of events 6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
66.7%
4/6 • Number of events 8 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 5 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
83.3%
5/6 • Number of events 8 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood albumin decreased
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
45.5%
5/11 • Number of events 7 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
66.7%
4/6 • Number of events 5 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood amylase increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood magnesium increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
50.0%
3/6 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
50.0%
3/6 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
54.5%
6/11 • Number of events 10 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
33.3%
2/6 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
International normalised ratio increased
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Prothrombin time prolonged
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Red blood cell count decreased
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
33.3%
2/6 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
63.6%
7/11 • Number of events 7 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
66.7%
2/3 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
72.7%
8/11 • Number of events 15 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
66.7%
4/6 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hyperinsulinaemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
45.5%
5/11 • Number of events 5 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
50.0%
3/6 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
33.3%
2/6 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
33.3%
2/6 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
27.3%
3/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
45.5%
5/11 • Number of events 5 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 4 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
33.3%
2/6 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
3/3 • Number of events 3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
63.6%
7/11 • Number of events 9 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
36.4%
4/11 • Number of events 7 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
33.3%
1/3 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
16.7%
1/6 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
18.2%
2/11 • Number of events 2 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
9.1%
1/11 • Number of events 1 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/11 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
0.00%
0/6 • Up to 36 weeks (up to 4 weeks following cessation of study treatment)
All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; AEs were not collected for Part 2-specific arms.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER