Trial Outcomes & Findings for A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies (NCT NCT03241173)
NCT ID: NCT03241173
Last Updated: 2022-09-27
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
up to 17.4 months
Results posted on
2022-09-27
Participant Flow
This study was conducted at 13 study centers in the United States in two parts: dose escalation (Part 1) and safety expansion (Part 2).
Participant milestones
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors were to have received INCAGN01949 at the assigned dose level Q2W in combination with nivolumab 3 mg/kg Q2W and ipilimumab 1 mg/kg Q6W, all administered as IV infusions beginning on Cycle 1 Day 1.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic solid tumors were to have received INCAGN01949 at the assigned dose level Q2W beginning on Cycle 1 Day 1, in combination with nivolumab 3 mg/kg Q2W beginning on Cycle 3 Day 1 and ipilimumab 1 mg/kg Q6W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 2, Part A: INCAGN01949 + Nivolumab
Programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) refractory participants with gastric cancer, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC) were to have received a range of doses of INCAGN01949 found to be safe in Phase 1 in combination with nivolumab, administered as IV infusions.
|
Phase 2, Part B: INCAGN01949; INCAGN01949 + Nivolumab; INCAGN01949 + Nivolumab + Ipilimumab
PD-1/L1 refractory participants with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC were to have received a range of doses of INCAGN01949 found to be safe in Phase 1. INCAGN01949 was to have been administered alone, in combination with nivolumab, and in combination with nivolumab and ipilimumab, administered as IV infusions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
5
|
4
|
5
|
4
|
3
|
0
|
6
|
6
|
6
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
5
|
5
|
4
|
5
|
4
|
3
|
0
|
6
|
6
|
6
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors were to have received INCAGN01949 at the assigned dose level Q2W in combination with nivolumab 3 mg/kg Q2W and ipilimumab 1 mg/kg Q6W, all administered as IV infusions beginning on Cycle 1 Day 1.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic solid tumors were to have received INCAGN01949 at the assigned dose level Q2W beginning on Cycle 1 Day 1, in combination with nivolumab 3 mg/kg Q2W beginning on Cycle 3 Day 1 and ipilimumab 1 mg/kg Q6W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 2, Part A: INCAGN01949 + Nivolumab
Programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) refractory participants with gastric cancer, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC) were to have received a range of doses of INCAGN01949 found to be safe in Phase 1 in combination with nivolumab, administered as IV infusions.
|
Phase 2, Part B: INCAGN01949; INCAGN01949 + Nivolumab; INCAGN01949 + Nivolumab + Ipilimumab
PD-1/L1 refractory participants with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC were to have received a range of doses of INCAGN01949 found to be safe in Phase 1. INCAGN01949 was to have been administered alone, in combination with nivolumab, and in combination with nivolumab and ipilimumab, administered as IV infusions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
3
|
2
|
4
|
4
|
2
|
2
|
3
|
1
|
0
|
5
|
4
|
3
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Survival Follow-up No Longer Required per Protocol Amendment
|
1
|
2
|
0
|
1
|
1
|
2
|
1
|
2
|
0
|
0
|
2
|
3
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
Baseline characteristics by cohort
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
n=3 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 7.53 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 3.16 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 5.00 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 8.07 • n=4 Participants
|
58.5 years
STANDARD_DEVIATION 6.45 • n=21 Participants
|
60.6 years
STANDARD_DEVIATION 10.21 • n=10 Participants
|
59.3 years
STANDARD_DEVIATION 12.71 • n=115 Participants
|
50.0 years
STANDARD_DEVIATION 20.52 • n=6 Participants
|
60.5 years
STANDARD_DEVIATION 8.73 • n=6 Participants
|
55.7 years
STANDARD_DEVIATION 15.96 • n=64 Participants
|
64.0 years
STANDARD_DEVIATION 13.96 • n=17 Participants
|
58.77 years
STANDARD_DEVIATION 11.48 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
4 Participants
n=17 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
48 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
5 Participants
n=17 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 17.4 monthsPopulation: Full Analysis Set (FAS): all participants enrolled in the study who received ≥ 1 dose of INCAGN01949, nivolumab, or ipilimumab
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Outcome measures
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
n=3 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
4 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: up to 17.4 monthsPopulation: FAS
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death due to AE.
Outcome measures
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
n=3 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With a Grade 3 or Higher TEAE
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: up to 24 monthsPopulation: Phase 2 of the study did not open for enrollment.
ORR was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by investigator assessment of radiographic disease assessments, recorded before and including the first event of progressive disease (PD). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 15.6 monthsPopulation: FAS
ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, per RECIST v1.1, as determined by investigator assessment of radiographic disease assessments, recorded before and including the first event of PD. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
n=3 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: ORR
|
25.0 percentage of participants
|
25.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: up to 11.0 monthsPopulation: FAS. The confidence interval was calculated using the method of Brookmeyer and Crowley. Only participants with a confirmed CR or PR were analyzed.
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or first assessment of PD, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Response (DOR)
|
97.0 days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA days
The median and upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
86.0 days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Phase 2 of the study did not open for enrollment.
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or first assessment of PD, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 15.6 monthsPopulation: FAS
DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
n=3 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR)
|
25.0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
0.0 percentage of participants
|
75.0 percentage of participants
|
0.0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Phase 2 of the study did not open for enrollment.
DCR was defined as the percentage of participants with a CR, PR, or SD, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 15.4 monthsPopulation: FAS. The confidence interval was calculated based on the exact method for binomial distributions. Only participants with a confirmed CR, PR, or SD were analyzed.
Duration of disease control (CR, PR, and SD) was measured from the first report of SD or better until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. SD: no change in target lesions to qualify for CR, PR, or PD. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
n=2 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
n=3 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
n=2 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
n=1 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
n=2 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=2 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Disease Control
|
97.0 days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA days
The median and upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
120.0 days
Interval 61.0 to 179.0
|
—
|
58.0 days
Interval 43.0 to 113.0
|
—
|
298.5 days
Interval 169.0 to 428.0
|
100.0 days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
252.0 days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
117.0 days
Interval 86.0 to 148.0
|
115.0 days
Interval 52.0 to 418.0
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Phase 2 of the study did not open for enrollment.
Duration of disease control (CR, PR, and SD) was measured from the first report of SD or better until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. SD: no change in target lesions to qualify for CR, PR, or PD. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 15.6 monthsPopulation: FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval was calculated using the method of Brookmeyer and Crowley. Only participants with events of disease progression or death were analyzed.
PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1.
Outcome measures
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=3 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
n=3 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
n=6 Participants
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Progression-free Survival (PFS)
|
1.8 days
Interval 1.0 to 4.9
|
1.8 days
Interval 1.4 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
2.7 days
Interval 1.4 to 7.5
|
1.8 days
Interval 0.8 to 2.1
|
3.5 days
Interval 0.7 to 5.4
|
1.6 days
Interval 1.2 to 1.8
|
4.6 days
Interval 1.2 to 15.7
|
1.8 days
Interval 1.7 to 5.1
|
1.6 days
Interval 0.1 to 9.9
|
2.2 days
Interval 1.8 to 6.7
|
4.6 days
Interval 1.8 to 15.5
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Phase 2 of the study did not open for enrollment.
PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Phase 2 of the study did not open for enrollment.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Phase 2 of the study did not open for enrollment.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using CTCAE v4.03. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death due to AE.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
Serious events: 4 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Total
Serious events: 28 serious events
Other events: 52 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
n=5 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
n=5 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
n=4 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
n=5 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
n=4 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
n=3 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
n=6 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=6 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
n=6 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Total
n=52 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Death
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Fatigue
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Haematemesis
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
21.2%
11/52 • Number of events 11 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
Other adverse events
| Measure |
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
n=5 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
n=5 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
n=4 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
n=5 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
n=4 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
n=3 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
n=6 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
n=6 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
n=6 participants at risk
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
|
Total
n=52 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
75.0%
3/4 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
26.9%
14/52 • Number of events 14 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
11.5%
6/52 • Number of events 8 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
19.2%
10/52 • Number of events 12 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
19.2%
10/52 • Number of events 12 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
11.5%
6/52 • Number of events 7 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Asthenia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
17.3%
9/52 • Number of events 11 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Blood calcium increased
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
11.5%
6/52 • Number of events 7 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Blood pressure increased
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Eye disorders
Cataract
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Chest pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Chills
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
13.5%
7/52 • Number of events 7 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
13.5%
7/52 • Number of events 7 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
60.0%
3/5 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
17.3%
9/52 • Number of events 11 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
19.2%
10/52 • Number of events 12 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
11.5%
6/52 • Number of events 7 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
66.7%
2/3 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
11.5%
6/52 • Number of events 8 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Early satiety
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Ear and labyrinth disorders
Eustachian tube obstruction
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Face oedema
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Fatigue
|
100.0%
4/4 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
75.0%
3/4 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
51.9%
27/52 • Number of events 30 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Vascular disorders
Flushing
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Eye disorders
Halo vision
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
13.5%
7/52 • Number of events 11 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Hypersplenism
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
100.0%
3/3 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
13.5%
7/52 • Number of events 7 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
60.0%
3/5 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
13.5%
7/52 • Number of events 9 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Malaise
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Melaena
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Mucous membrane disorder
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
75.0%
3/4 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 7 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
36.5%
19/52 • Number of events 26 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm swelling
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
66.7%
2/3 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
17.3%
9/52 • Number of events 11 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 7 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
26.9%
14/52 • Number of events 17 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
40.0%
2/5 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
19.2%
10/52 • Number of events 11 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Nervous system disorders
Restless legs syndrome
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Immune system disorders
Seasonal allergy
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
General disorders
Swelling
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Cardiac disorders
Tachycardia
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Endocrine disorders
Thyroiditis
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
75.0%
3/4 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
3.8%
2/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
50.0%
2/4 • Number of events 2 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
5.8%
3/52 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
2/6 • Number of events 3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
50.0%
3/6 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
19.2%
10/52 • Number of events 13 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
20.0%
1/5 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
9.6%
5/52 • Number of events 5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
Weight increased
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
16.7%
1/6 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
7.7%
4/52 • Number of events 4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
|
Investigations
White blood cell count increased
|
25.0%
1/4 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/5 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/4 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/3 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
0.00%
0/6 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
1.9%
1/52 • Number of events 1 • up to 17.4 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER