Trial Outcomes & Findings for A Study of Dalotuzumab + MK-2206, Dalotuzumab + MK-0752, and Dalotuzumab + Ridaforolimus Combination Therapies in Participants With Advanced Cancer (MK-0646-027) (NCT NCT01243762)
NCT ID: NCT01243762
Last Updated: 2018-08-16
Results Overview
DLTs were defined as follows: 1) non-hematological toxicity ≥Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 except for Grade 3 nausea, vomiting, diarrhea, and/or dehydration; Grade 3 or 4 hyperglycemia; alopecia; inadequately treated hypersensitivity reactions; dalotuzumab infusion-related reactions; Grade 3 transaminases ≤1 week in duration; or clinically non-significant, treatable or reversible lab abnormalities; 2) Grade 4-5 hematologic toxicity, with the exception of Grade 4 neutropenia \<6 days in duration; 3) Grade 3 or Grade 4 neutropenia with fever \>38.5 degrees C; 4) Grade 4 thrombocytopenia ≤25.0 x 10\^9/Liter; 5) drug-related adverse experience leading to a dose modification during Cycle 1; 6) unresolved drug-related toxicity that causes ≥3 week delay of the next scheduled dose of study medication; 7) persistent increases in QTc interval \>60 milliseconds from baseline, or clinically significant bradycardia.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Cycle 1-28 Days
Results posted on
2018-08-16
Participant Flow
41 participants enrolled in Part 1 (dose escalation/preliminary maximum tolerated dose \[MTD\] identification). 12 participants continued in Part 2 (preliminary anti-tumor activity assessment), and 6 new participants were enrolled in Part 2 that did not participate in Part 1 (total enrollment = 47). Study terminated prior to completion of Part 2.
Participant milestones
| Measure |
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg
Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-0752 1800 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 90 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 135 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 150 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 200 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab + Ridaforolimus
Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
|---|---|---|---|---|---|---|---|
|
Part 1 (Dose Escalation/MTD)
STARTED
|
4
|
13
|
3
|
8
|
10
|
3
|
0
|
|
Part 1 (Dose Escalation/MTD)
COMPLETED
|
1
|
5
|
0
|
2
|
4
|
0
|
0
|
|
Part 1 (Dose Escalation/MTD)
NOT COMPLETED
|
3
|
8
|
3
|
6
|
6
|
3
|
0
|
|
Part 2 (Dose Confirmation/Efficacy)
STARTED
|
1
|
5
|
0
|
2
|
4
|
0
|
6
|
|
Part 2 (Dose Confirmation/Efficacy)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Dose Confirmation/Efficacy)
NOT COMPLETED
|
1
|
5
|
0
|
2
|
4
|
0
|
6
|
Reasons for withdrawal
| Measure |
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg
Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-0752 1800 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 90 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 135 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 150 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 200 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab + Ridaforolimus
Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
|---|---|---|---|---|---|---|---|
|
Part 1 (Dose Escalation/MTD)
Adverse Event
|
0
|
2
|
0
|
0
|
1
|
1
|
0
|
|
Part 1 (Dose Escalation/MTD)
Physician Decision
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Part 1 (Dose Escalation/MTD)
Progressive Disease
|
3
|
2
|
3
|
5
|
5
|
2
|
0
|
|
Part 1 (Dose Escalation/MTD)
Withdrawal by Subject
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Dose Confirmation/Efficacy)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
3
|
|
Part 2 (Dose Confirmation/Efficacy)
Progressive Disease
|
1
|
3
|
0
|
1
|
2
|
0
|
3
|
|
Part 2 (Dose Confirmation/Efficacy)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Part 2 (Dose Confirmation/Efficacy)
Physician Decision
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Dalotuzumab + MK-2206, Dalotuzumab + MK-0752, and Dalotuzumab + Ridaforolimus Combination Therapies in Participants With Advanced Cancer (MK-0646-027)
Baseline characteristics by cohort
| Measure |
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg
n=4 Participants
Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-0752 1800 mg
n=13 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 90 mg
n=3 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 135 mg
n=8 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 150 mg
n=10 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 200 mg
n=3 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab + Ridaforolimus
n=6 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.8 Years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
59.0 Years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
50.3 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
60.4 Years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
65.4 Years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
57.3 Years
STANDARD_DEVIATION 10.1 • n=10 Participants
|
68.8 Years
STANDARD_DEVIATION 14.1 • n=115 Participants
|
60.6 Years
STANDARD_DEVIATION 11.6 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
33 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
14 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Cycle 1-28 DaysPopulation: All participants who completed the first cycle of study therapy or discontinued from the study due to a DLT attributable to study therapy.
DLTs were defined as follows: 1) non-hematological toxicity ≥Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 except for Grade 3 nausea, vomiting, diarrhea, and/or dehydration; Grade 3 or 4 hyperglycemia; alopecia; inadequately treated hypersensitivity reactions; dalotuzumab infusion-related reactions; Grade 3 transaminases ≤1 week in duration; or clinically non-significant, treatable or reversible lab abnormalities; 2) Grade 4-5 hematologic toxicity, with the exception of Grade 4 neutropenia \<6 days in duration; 3) Grade 3 or Grade 4 neutropenia with fever \>38.5 degrees C; 4) Grade 4 thrombocytopenia ≤25.0 x 10\^9/Liter; 5) drug-related adverse experience leading to a dose modification during Cycle 1; 6) unresolved drug-related toxicity that causes ≥3 week delay of the next scheduled dose of study medication; 7) persistent increases in QTc interval \>60 milliseconds from baseline, or clinically significant bradycardia.
Outcome measures
| Measure |
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg
n=4 Participants
Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-0752 1800 mg
n=13 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 90 mg
n=3 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 135 mg
n=8 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 150 mg
n=10 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 200 mg
n=3 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab + Ridaforolimus
n=3 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: All participants who received at least one dose of study therapy and had baseline data for those analyses that required baseline data. The analysis was planned to be performed on the 3 arms in Part 2 only. The study was terminated prior to completion of this analysis.
Best response was determined for the maximum tolerated dose from the start of treatment until disease progression, recurrence, or completion of 6 months of treatment. Lesions were measured by computed tomography (CT) scan or magnetic resonance imaging (MRI). Partial response (PR), defined as a tumor burden decrease of 30%, or complete response (CR) was determined using Response Criteria in Solid Tumors (RECIST) 1.1 for participants with at least one measurable target lesion at baseline.
Outcome measures
| Measure |
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg
n=6 Participants
Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-0752 1800 mg
n=6 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 90 mg
n=6 Participants
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 135 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 150 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 200 mg
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab + Ridaforolimus
Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Whose Best Response is a Partial Response (PR) or Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Dalotuzumab 10 mg/kg + MK-0752 1800 mg
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Dalotuzumab 10 mg/kg + MK-2206 90 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dalotuzumab 10 mg/kg + MK-2206 135 mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Dalotuzumab 10 mg/kg + MK-2206 150 mg
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Dalotuzumab 10 mg/kg + MK-2206 200 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Dalotuzumab + Ridaforolimus
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg
n=4 participants at risk
Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-0752 1800 mg
n=13 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 90 mg
n=3 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 135 mg
n=8 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 150 mg
n=10 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 200 mg
n=3 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab + Ridaforolimus
n=6 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Infectious peritonitis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Electrocardiogram QT prolonged
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
Other adverse events
| Measure |
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg
n=4 participants at risk
Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-0752 1800 mg
n=13 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 90 mg
n=3 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 135 mg
n=8 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 150 mg
n=10 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab 10 mg/kg + MK-2206 200 mg
n=3 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
Dalotuzumab + Ridaforolimus
n=6 participants at risk
Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
75.0%
3/4 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
37.5%
3/8 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
5/10 • Number of events 6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
23.1%
3/13 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Eye disorders
Orbital oedema
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Eye disorders
Photopsia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Abdominal distension
|
50.0%
2/4 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Abdominal pain
|
75.0%
3/4 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
5/10 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
66.7%
2/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
40.0%
4/10 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
3/4 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
38.5%
5/13 • Number of events 7 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
4/8 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
40.0%
4/10 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.0%
3/10 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
76.9%
10/13 • Number of events 10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
4/8 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.0%
3/10 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
66.7%
2/3 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Oesophagitis
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.0%
3/10 • Number of events 7 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
3/4 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
53.8%
7/13 • Number of events 7 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.0%
3/10 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Asthenia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Chest pain
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Chills
|
50.0%
2/4 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
69.2%
9/13 • Number of events 9 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
75.0%
6/8 • Number of events 7 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
80.0%
8/10 • Number of events 10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
100.0%
3/3 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Gait disturbance
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Implant site haemorrhage
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Localised oedema
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Oedema
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Oedema peripheral
|
75.0%
3/4 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
66.7%
2/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
General disorders
Secretion discharge
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Immune system disorders
Serum sickness-like reaction
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Injury, poisoning and procedural complications
Chemical eye injury
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
66.7%
2/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
38.5%
5/13 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 7 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
38.5%
5/13 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
23.1%
3/13 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
23.1%
3/13 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Haemoglobin decreased
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
International normalised ratio increased
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
Weight decreased
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.8%
4/13 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
62.5%
5/8 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Decreased appetite
|
75.0%
3/4 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
61.5%
8/13 • Number of events 9 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
62.5%
5/8 • Number of events 6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
40.0%
4/10 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
100.0%
3/3 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.8%
4/13 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
37.5%
3/8 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
5/10 • Number of events 7 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
83.3%
5/6 • Number of events 9 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
2/4 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
23.1%
3/13 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal wall
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Ageusia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
37.5%
3/8 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.0%
3/10 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
23.1%
3/13 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
37.5%
3/8 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.0%
3/10 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Parosmia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Psychiatric disorders
Personality change
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.8%
4/13 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
3/6 • Number of events 6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
50.0%
2/4 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
15.4%
2/13 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
2/6 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
25.0%
2/8 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
37.5%
3/8 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
5/10 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.0%
3/10 • Number of events 4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
66.7%
2/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
50.0%
4/8 • Number of events 9 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
20.0%
2/10 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
40.0%
4/10 • Number of events 5 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
66.7%
2/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
7.7%
1/13 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Vascular disorders
Deep vein thrombosis
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
10.0%
1/10 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
16.7%
1/6 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
30.0%
3/10 • Number of events 3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
12.5%
1/8 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
33.3%
1/3 • Number of events 2 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
|
Vascular disorders
Vasculitis
|
25.0%
1/4 • Number of events 1 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/13 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/8 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/10 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/3 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
0.00%
0/6 • Up to 7 months
Adverse events collected for all participants who received at least one dose of study therapy
|
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 review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation and can delete information identified as confidential prior to submission.
- Publication restrictions are in place
Restriction type: OTHER