Trial Outcomes & Findings for Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Acute Lymphoblastic Leukemia (B-ALL) (NCT NCT02669264)
NCT ID: NCT02669264
Last Updated: 2021-05-24
Results Overview
A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as: \- Grade 3 or higher event of neutropenia or thrombocytopenia, or a Grade 4 anemia, with a hypocellular bone marrow lasting for 6 weeks or more after the start of a cycle, in the absence of residual leukemia (i.e., with \<5% blasts). In case of a normocellular bone marrow with \<5% blasts, 8 weeks with ≥Grade 3 pancytopenia will be considered a DLT. A non-hematologic DLT is defined as: * Grade 4 tumor lysis syndrome (Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage). * Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia). * CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication). * CTCAE Grade 3 or higher skin ulceration.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Day 1 to End of Cycle 1 (3 weeks)
Results posted on
2021-05-24
Participant Flow
Participant milestones
| Measure |
15 μg/kg Q3W
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
3
|
4
|
5
|
6
|
5
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
3
|
3
|
5
|
6
|
5
|
Reasons for withdrawal
| Measure |
15 μg/kg Q3W
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
5
|
3
|
3
|
3
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Miscellaneous
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Height data was not collected for 3 participants because of complications during the collection of baseline measurements.
Baseline characteristics by cohort
| Measure |
15 μg/kg Q3W
n=5 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=7 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=3 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=4 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=5 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=6 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
n=5 Participants
Participants received 50 μg/kg ADCT-402 on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the QW dosing was based on the safety and tolerability of participants who have been treated on the every 3-week (Q3W) schedule.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 21.22 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 21.95 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 6.51 • n=3 Participants
|
63.8 years
STANDARD_DEVIATION 7.09 • n=4 Participants
|
46.8 years
STANDARD_DEVIATION 18.14 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 19.61 • n=6 Participants
|
42.8 years
STANDARD_DEVIATION 24.30 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 18.66 • n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
27 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
35 Participants
n=35 Participants
|
|
Height
|
162.40 cm
STANDARD_DEVIATION 8.510 • n=5 Participants • Height data was not collected for 3 participants because of complications during the collection of baseline measurements.
|
167.97 cm
STANDARD_DEVIATION 17.050 • n=7 Participants • Height data was not collected for 3 participants because of complications during the collection of baseline measurements.
|
162.60 cm
STANDARD_DEVIATION 0.000 • n=2 Participants • Height data was not collected for 3 participants because of complications during the collection of baseline measurements.
|
164.78 cm
STANDARD_DEVIATION 11.943 • n=4 Participants • Height data was not collected for 3 participants because of complications during the collection of baseline measurements.
|
172.32 cm
STANDARD_DEVIATION 10.146 • n=5 Participants • Height data was not collected for 3 participants because of complications during the collection of baseline measurements.
|
163.58 cm
STANDARD_DEVIATION 7.398 • n=5 Participants • Height data was not collected for 3 participants because of complications during the collection of baseline measurements.
|
155.75 cm
STANDARD_DEVIATION 5.072 • n=4 Participants • Height data was not collected for 3 participants because of complications during the collection of baseline measurements.
|
164.83 cm
STANDARD_DEVIATION 11.211 • n=32 Participants • Height data was not collected for 3 participants because of complications during the collection of baseline measurements.
|
|
Weight
|
76.44 kg
STANDARD_DEVIATION 26.043 • n=5 Participants
|
93.80 kg
STANDARD_DEVIATION 31.551 • n=7 Participants
|
87.13 kg
STANDARD_DEVIATION 13.301 • n=3 Participants
|
58.33 kg
STANDARD_DEVIATION 15.745 • n=4 Participants
|
78.00 kg
STANDARD_DEVIATION 11.663 • n=5 Participants
|
83.05 kg
STANDARD_DEVIATION 38.842 • n=6 Participants
|
70.58 kg
STANDARD_DEVIATION 11.576 • n=5 Participants
|
79.28 kg
STANDARD_DEVIATION 25.631 • n=35 Participants
|
|
Body Mass Index (BMI)
|
28.62 kg/m^2
STANDARD_DEVIATION 7.192 • n=5 Participants • BMI could not be calculated for 3 participants due to missing height information.
|
34.05 kg/m^2
STANDARD_DEVIATION 13.059 • n=7 Participants • BMI could not be calculated for 3 participants due to missing height information.
|
30.43 kg/m^2
STANDARD_DEVIATION 3.504 • n=2 Participants • BMI could not be calculated for 3 participants due to missing height information.
|
21.07 kg/m^2
STANDARD_DEVIATION 3.356 • n=4 Participants • BMI could not be calculated for 3 participants due to missing height information.
|
26.22 kg/m^2
STANDARD_DEVIATION 2.949 • n=5 Participants • BMI could not be calculated for 3 participants due to missing height information.
|
32.70 kg/m^2
STANDARD_DEVIATION 12.605 • n=5 Participants • BMI could not be calculated for 3 participants due to missing height information.
|
27.93 kg/m^2
STANDARD_DEVIATION 5.741 • n=4 Participants • BMI could not be calculated for 3 participants due to missing height information.
|
29.15 kg/m^2
STANDARD_DEVIATION 9.142 • n=32 Participants • BMI could not be calculated for 3 participants due to missing height information.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
|
1.00 Score on a scale
STANDARD_DEVIATION 0.000 • n=5 Participants
|
1.29 Score on a scale
STANDARD_DEVIATION 0.488 • n=7 Participants
|
0.67 Score on a scale
STANDARD_DEVIATION 0.577 • n=3 Participants
|
1.50 Score on a scale
STANDARD_DEVIATION 0.577 • n=4 Participants
|
1.60 Score on a scale
STANDARD_DEVIATION 0.548 • n=5 Participants
|
1.33 Score on a scale
STANDARD_DEVIATION 1.033 • n=6 Participants
|
1.40 Score on a scale
STANDARD_DEVIATION 0.548 • n=5 Participants
|
1.29 Score on a scale
STANDARD_DEVIATION 0.622 • n=35 Participants
|
PRIMARY outcome
Timeframe: Day 1 to End of Cycle 1 (3 weeks)Population: Safety analysis set
A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as: \- Grade 3 or higher event of neutropenia or thrombocytopenia, or a Grade 4 anemia, with a hypocellular bone marrow lasting for 6 weeks or more after the start of a cycle, in the absence of residual leukemia (i.e., with \<5% blasts). In case of a normocellular bone marrow with \<5% blasts, 8 weeks with ≥Grade 3 pancytopenia will be considered a DLT. A non-hematologic DLT is defined as: * Grade 4 tumor lysis syndrome (Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage). * Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia). * CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication). * CTCAE Grade 3 or higher skin ulceration.
Outcome measures
| Measure |
15 μg/kg Q3W
n=5 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=7 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=3 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=4 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=5 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=6 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
n=5 Participants
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to End of Cycle 1 (3 weeks)Population: This analysis was planned, but data was not collected as the study was terminated prematurely.
The recommended dose was to be established by the dose escalation steering committee and based on safety findings during part 1 of the study.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)Population: Safety analysis set
An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.
Outcome measures
| Measure |
15 μg/kg Q3W
n=5 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=7 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=3 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=4 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=5 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=6 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
n=5 Participants
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)
|
5 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment-emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
15 μg/kg Q3W
n=5 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=7 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=3 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=4 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=5 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=6 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
n=5 Participants
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
|
5 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drugPopulation: This analysis was planned, but data was not collected as the study was terminated prematurely.
ORR is defined as the number of participants with a best overall response of complete response (CR), complete response with incomplete blood count recovery (Cri) or partial response (PR) at the time each participant discontinues treatment with ADCT-402. CR is defined as achieving each of the following: * Bone marrow differential showing ≤5% blast cells. * Absolute neutrophil count (ANC) ≥1.0 x 10\^9/L and platelet count ≥100 x 10\^9/L. * Absence of extramedullary disease. * Participant is independent of red blood cell transfusions. Cri is defined as achieving all CR criteria except that values for ANC may be \<1.0 x 10\^9/L and/or values for platelets may be \<100 x 10\^9/L. PR is defined as achieving each of the following: * ANC ≥1.0 x 10\^9/L and platelet count ≥100 x 10\^9/L. * Bone marrow differential showing a ≥50% decrease from baseline in the percentage of bone marrow blast cells to a level \>5% and ≤25%, or bone marrow differential showing \<5% blast cells.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drugPopulation: This analysis was planned, but data was not collected as the study was terminated prematurely.
Duration of response is defined among responders (complete response \[CR\], complete response with incomplete blood count recovery \[Cri\], and partial response \[PR\]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Disease progression is defined as: * For participants with CR or CRi, the first date of reappearance of blast cells in bone marrow and/or peripheral blood to a level ≥5%, or development of extramedullary disease. * For participants with PR, the first date of an increase in blast cells in bone marrow and/or peripheral blood such that the patient does not continue to meet the criteria for PR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drugPopulation: This analysis was planned, but data was not collected as the study was terminated prematurely.
Overall survival is defined as the time from the first dose of study drug treatment until the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drugPopulation: This analysis was planned, but data was not collected as the study was terminated prematurely.
Progression-free survival is defined among the efficacy population as the time from first dose of study drug until the first date of either disease progression or death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Outcome measures
| Measure |
15 μg/kg Q3W
n=5 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=7 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=3 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=4 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=5 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=6 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 2
|
—
|
0.0459 µg/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.0697 µg/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.0551 µg/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.108 µg/L
Standard Deviation 0.0239
|
0.0550 µg/L
Standard Deviation 0.0277
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 1
|
178 µg/L
Standard Deviation 128
|
258 µg/L
Standard Deviation 162
|
449 µg/L
Standard Deviation 282
|
1058 µg/L
Standard Deviation 893
|
1291 µg/L
Standard Deviation 1020
|
2145 µg/L
Standard Deviation 1054
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 2
|
2150 µg/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
339 µg/L
Standard Deviation 276
|
661 µg/L
Standard Deviation 412
|
1813 µg/L
Standard Deviation 1650
|
1515 µg/L
Standard Deviation 1001
|
3033 µg/L
Standard Deviation 1458
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 1
|
205 µg/L
Standard Deviation 162
|
317 µg/L
Standard Deviation 194
|
717 µg/L
Standard Deviation 429
|
1049 µg/L
Standard Deviation 892
|
1722 µg/L
Standard Deviation 785
|
2761 µg/L
Standard Deviation 1718
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 2
|
1251 µg/L
Standard Deviation 1724
|
366 µg/L
Standard Deviation 251
|
689 µg/L
Standard Deviation 382
|
1845 µg/L
Standard Deviation 1676
|
2125 µg/L
Standard Deviation 944
|
4338 µg/L
Standard Deviation 2460
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 1
|
—
|
0.0428 µg/L
Standard Deviation 0.0000707
|
—
|
0.0617 µg/L
Standard Deviation 0.0238
|
0.0810 µg/L
Standard Deviation 0.0288
|
0.0907 µg/L
Standard Deviation 0.0500
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Outcome measures
| Measure |
15 μg/kg Q3W
n=3 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 2
|
788 µg/L
Standard Deviation 456
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 1
|
444 µg/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 2
|
757 µg/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 2
|
480 µg/L
Standard Deviation 414
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 1
|
777 µg/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 3
|
773 µg/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 1
|
363 µg/L
Standard Deviation 390
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 2
|
544 µg/L
Standard Deviation 492
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 3
|
293 µg/L
Standard Deviation 313
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 1
|
300 µg/L
Standard Deviation 294
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 3
|
730 µg/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Outcome measures
| Measure |
15 μg/kg Q3W
n=4 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=7 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=3 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=3 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=5 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=6 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 1
|
0.0600 days
Standard Deviation 0.0216
|
0.0729 days
Standard Deviation 0.0547
|
0.0450 days
Standard Deviation 0.00707
|
0.0433 days
Standard Deviation 0.00577
|
0.0450 days
Standard Deviation 0.00577
|
0.0517 days
Standard Deviation 0.00983
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 1
|
0.0525 days
Standard Deviation 0.00957
|
0.0671 days
Standard Deviation 0.0547
|
0.0433 days
Standard Deviation 0.00577
|
0.0567 days
Standard Deviation 0.0208
|
0.0460 days
Standard Deviation 0.00548
|
0.0517 days
Standard Deviation 0.00983
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab: Cycle 2
|
0.0600 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.0475 days
Standard Deviation 0.0250
|
0.0300 days
Standard Deviation 0.0141
|
0.0500 days
Standard Deviation 0.0424
|
0.0500 days
Standard Deviation 0.0212
|
0.0525 days
Standard Deviation 0.0250
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 2
|
0.0600 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.0700 days
Standard Deviation 0.0678
|
0.0300 days
Standard Deviation 0.0141
|
0.0500 days
Standard Deviation 0.0424
|
0.0600 days
Standard Deviation 0.0141
|
0.0625 days
Standard Deviation 0.0263
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 1
|
—
|
0.0600 days
Standard Deviation 0.0283
|
—
|
0.125 days
Standard Deviation 0.0636
|
0.0867 days
Standard Deviation 0.00577
|
0.395 days
Standard Deviation 0.777
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 2
|
—
|
0.0600 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.0600 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.0400 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.0867 days
Standard Deviation 0.00577
|
0.0600 days
Standard Deviation 0.0283
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Outcome measures
| Measure |
15 μg/kg Q3W
n=3 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 3
|
0.110 days
Standard Deviation 0.0849
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 1
|
0.0500 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 2
|
0.0400 days
Standard Deviation 0.0141
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 1
|
0.0400 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 2
|
0.0400 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 3
|
0.0400 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 1
|
0.0500 days
Standard Deviation 0.0100
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 2
|
0.697 days
Standard Deviation 1.14
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 1
|
0.0400 days
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 2
|
0.0300 days
Standard Deviation 0.0141
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 3
|
0.0400 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Outcome measures
| Measure |
15 μg/kg Q3W
n=4 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=7 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=3 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=3 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=5 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=6 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 2
|
1012 day*ug/L
Standard Deviation 1301
|
1140 day*ug/L
Standard Deviation 2096
|
40.2 day*ug/L
Standard Deviation 0.0244
|
3671 day*ug/L
Standard Deviation 5062
|
13519 day*ug/L
Standard Deviation 22799
|
10493 day*ug/L
Standard Deviation 2021
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 1
|
337 day*ug/L
Standard Deviation 651
|
127 day*ug/L
Standard Deviation 229
|
43.0 day*ug/L
Standard Deviation 37.3
|
671 day*ug/L
Standard Deviation 1083
|
3907 day*ug/L
Standard Deviation 8159
|
688 day*ug/L
Standard Deviation 570
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 2
|
1596 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
735 day*ug/L
Standard Deviation 1400
|
50.6 day*ug/L
Standard Deviation 9.08
|
3370 day*ug/L
Standard Deviation 4562
|
8744 day*ug/L
Standard Deviation 17745
|
7553 day*ug/L
Standard Deviation 727
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 1
|
610 day*ug/L
Standard Deviation 1190
|
408 day*ug/L
Standard Deviation 623
|
59.9 day*ug/L
Standard Deviation 43.5
|
558 day*ug/L
Standard Deviation 899
|
5718 day*ug/L
Standard Deviation 9648
|
1091 day*ug/L
Standard Deviation 673
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 1
|
—
|
0.00355 day*ug/L
Standard Deviation 0.00147
|
—
|
0.00930 day*ug/L
Standard Deviation 0.00675
|
0.0194 day*ug/L
Standard Deviation 0.0231
|
0.0338 day*ug/L
Standard Deviation 0.0150
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 2
|
—
|
0.00522 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.0129 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.00830 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.0433 day*ug/L
Standard Deviation 0.0316
|
0.00927 day*ug/L
Standard Deviation 0.00881
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Outcome measures
| Measure |
15 μg/kg Q3W
n=3 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 1
|
518 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 2
|
1063 day*ug/L
Standard Deviation 1334
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 1
|
1548 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 2
|
2631 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 3
|
3918 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 1
|
464 day*ug/L
Standard Deviation 290
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 2
|
821 day*ug/L
Standard Deviation 886
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 3
|
1286 day*ug/L
Standard Deviation 1158
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 1
|
1157 day*ug/L
Standard Deviation 962
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 2
|
9.08 day*ug/L
Standard Deviation 9.78
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 3
|
3927 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Outcome measures
| Measure |
15 μg/kg Q3W
n=1 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=2 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=1 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=3 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=2 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=5 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 1
|
1378 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
395 day*ug/L
Standard Deviation 371
|
—
|
677 day*ug/L
Standard Deviation 1091
|
282 day*ug/L
Standard Deviation 324
|
486 day*ug/L
Standard Deviation 259
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 1
|
—
|
535 day*ug/L
Standard Deviation 668
|
94.1 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
1634 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
1140 day*ug/L
Standard Deviation 1283
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Outcome measures
| Measure |
15 μg/kg Q3W
n=1 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Weekly (QW)
PBD-Conjugated Ab : Cycle 1 Week 1
|
545 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Outcome measures
| Measure |
15 μg/kg Q3W
n=1 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=3 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=2 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=2 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=4 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=4 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 2
|
1810 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
985 day*ug/L
Standard Deviation 1606
|
53.3 day*ug/L
Standard Deviation 9.99
|
3595 day*ug/L
Standard Deviation 4876
|
8282 day*ug/L
Standard Deviation 14386
|
7444 day*ug/L
Standard Deviation 831
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 2
|
2500 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
1607 day*ug/L
Standard Deviation 2330
|
41.2 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
7820 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
10198 day*ug/L
Standard Deviation 15433
|
10112 day*ug/L
Standard Deviation 1753
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 2
|
—
|
—
|
—
|
—
|
0.104 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Outcome measures
| Measure |
15 μg/kg Q3W
n=2 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 3
|
3542 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 2
|
1402 day*ug/L
Standard Deviation 1314
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 3
|
2066 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 2
|
1293 day*ug/L
Standard Deviation 1640
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 1
|
449 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 3
|
3463 day*ug/L
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.
Outcome measures
| Measure |
15 μg/kg Q3W
n=1 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=3 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=1 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=1 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=3 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=4 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Accumulation Index (AI) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 2
|
1.01 ratio
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
1.14 ratio
Standard Deviation 0.242
|
1.00 ratio
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
1.06 ratio
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
1.30 ratio
Standard Deviation 0.509
|
1.03 ratio
Standard Deviation 0.0187
|
—
|
|
Accumulation Index (AI) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 2
|
1.04 ratio
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
1.62 ratio
Standard Deviation 0.433
|
1.00 ratio
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
1.08 ratio
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
1.67 ratio
Standard Deviation 0.939
|
1.06 ratio
Standard Deviation 0.0532
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.
Outcome measures
| Measure |
15 μg/kg Q3W
n=2 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Accumulation Index (AI) for ADCT-402 Administered Weekly (QW)
PBD-Conjugated Ab : Cycle 1 Week 2
|
1.13 ratio
Standard Deviation 0.0410
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Accumulation Index (AI) for ADCT-402 Administered Weekly (QW)
Total Ab (ADCT-402) : Cycle 1 Week 2
|
2.52 ratio
Standard Deviation 1.92
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: This analysis was planned, but data was not collected as the study was terminated prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: This analysis was planned, but data was not collected as the study was terminated prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: This analysis was planned, but data was not collected as the study was terminated prematurely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Outcome measures
| Measure |
15 μg/kg Q3W
n=1 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=3 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=1 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=3 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=3 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=5 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 1
|
5.23 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
1.87 days
Standard Deviation 0.287
|
—
|
0.355 days
Standard Deviation 0.501
|
0.156 days
Standard Deviation 0.164
|
0.713 days
Standard Deviation 0.596
|
—
|
|
Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 2
|
2.91 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
4.31 days
Standard Deviation 6.62
|
0.282 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
4.96 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
7.55 days
Standard Deviation 10.3
|
3.99 days
Standard Deviation 0.723
|
—
|
|
Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 1
|
—
|
1.28 days
Standard Deviation 1.66
|
0.0538 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.784 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
0.275 days
Standard Deviation 0.306
|
—
|
|
Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 2
|
4.42 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
15.0 days
Standard Deviation 6.88
|
0.0342 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
5.59 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
14.5 days
Standard Deviation 16.4
|
4.67 days
Standard Deviation 1.68
|
—
|
|
Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 2
|
—
|
—
|
—
|
—
|
0.508 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Outcome measures
| Measure |
15 μg/kg Q3W
n=2 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 1
|
2.29 days
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 2
|
2.26 days
Standard Deviation 0.288
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 2
|
9.39 days
Standard Deviation 9.77
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Outcome measures
| Measure |
15 μg/kg Q3W
n=1 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=3 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=2 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=3 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=4 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=5 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 1
|
—
|
31.3 L/day
Standard Deviation 40.0
|
55.5 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
3.98 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
18.9 L/day
Standard Deviation 21.8
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 1
|
0.650 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
14.0 L/day
Standard Deviation 14.3
|
—
|
80.8 L/day
Standard Deviation 106
|
84.3 L/day
Standard Deviation 102
|
27.4 L/day
Standard Deviation 12.4
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 2
|
0.495 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
69.3 L/day
Standard Deviation 92.3
|
86.4 L/day
Standard Deviation 34.6
|
9.63 L/day
Standard Deviation 12.5
|
31.1 L/day
Standard Deviation 37.0
|
1.57 L/day
Standard Deviation 0.726
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 2
|
0.422 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
16.4 L/day
Standard Deviation 19.9
|
146 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
0.831 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
10.3 L/day
Standard Deviation 16.7
|
1.37 L/day
Standard Deviation 0.656
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 2
|
—
|
—
|
—
|
—
|
838 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Outcome measures
| Measure |
15 μg/kg Q3W
n=2 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 1
|
5.77 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 2
|
14.0 L/day
Standard Deviation 18.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 2 Week 3
|
1.01 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 2
|
5.23 L/day
Standard Deviation 5.16
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 3
|
2.03 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 1
|
8.46 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 2 Week 3
|
1.21 L/day
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.
Outcome measures
| Measure |
15 μg/kg Q3W
n=1 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=3 Participants
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=1 Participants
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=3 Participants
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=3 Participants
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=5 Participants
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 2
|
2.69 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
145 liters
Standard Deviation 190
|
7.22 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
6.71 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
11.4 liters
Standard Deviation 0.101
|
9.14 liters
Standard Deviation 5.96
|
—
|
|
Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 1
|
4.91 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
40.7 liters
Standard Deviation 44.3
|
—
|
10.5 liters
Standard Deviation 12.6
|
6.89 liters
Standard Deviation 3.13
|
34.2 liters
Standard Deviation 35.5
|
—
|
|
Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W)
PBD-Conjugated Ab : Cycle 2
|
2.08 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
24.0 liters
Standard Deviation 18.1
|
45.1 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
5.61 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
8.33 liters
Standard Deviation 5.43
|
9.45 liters
Standard Deviation 5.27
|
—
|
|
Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W)
Total Ab (ADCT-402) : Cycle 1
|
—
|
9.77 liters
Standard Deviation 1.09
|
4.31 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
4.50 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
2.68 liters
Standard Deviation 0.309
|
—
|
|
Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W)
SG3199 : Cycle 2
|
—
|
—
|
—
|
—
|
614 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Population: Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.
Outcome measures
| Measure |
15 μg/kg Q3W
n=2 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 1
|
19.1 liters
Standard Deviation NA
Standard deviation could not be determined as only one participant had evaluable data.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every Week (QW)
PBD-Conjugated Ab : Cycle 1 Week 2
|
49.5 liters
Standard Deviation 64.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every Week (QW)
Total Ab (ADCT-402): Cycle 1 Week 2
|
107 liters
Standard Deviation 144
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2Blood serum samples were collected and analysed to determine the presence or absence of ADA.
Outcome measures
| Measure |
15 μg/kg Q3W
n=35 Participants
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402
Confirmed positive ADA pre-dose
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402
Confirmed positive ADA post-dose
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402
Confirmed positive ADA at any time
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
15 μg/kg Q3W
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
30 μg/kg Q3W
Serious events: 4 serious events
Other events: 7 other events
Deaths: 5 deaths
60 μg/kg Q3W
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
90 μg/kg Q3W
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
120 μg/kg Q3W
Serious events: 5 serious events
Other events: 5 other events
Deaths: 3 deaths
150 μg/kg Q3W
Serious events: 5 serious events
Other events: 6 other events
Deaths: 6 deaths
50 μg/kg QW
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
15 μg/kg Q3W
n=5 participants at risk
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=7 participants at risk
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=3 participants at risk
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=4 participants at risk
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=5 participants at risk
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=6 participants at risk
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
n=5 participants at risk
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Asthenia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Disease progression
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Localised oedema
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Pyrexia
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Acute sinusitis
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
2/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Fungaemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
28.6%
2/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Blast cells present
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
Other adverse events
| Measure |
15 μg/kg Q3W
n=5 participants at risk
Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
30 μg/kg Q3W
n=7 participants at risk
Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
60 μg/kg Q3W
n=3 participants at risk
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
90 μg/kg Q3W
n=4 participants at risk
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
120 μg/kg Q3W
n=5 participants at risk
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
150 μg/kg Q3W
n=6 participants at risk
Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
|
50 μg/kg QW
n=5 participants at risk
Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
2/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
3/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
28.6%
2/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
28.6%
2/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
2/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
60.0%
3/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
83.3%
5/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
60.0%
3/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
3/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
3/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
2/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
28.6%
2/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Angina bullosa haemorrhagica
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
42.9%
3/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
75.0%
3/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Pyrexia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
3/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Asthenia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Chills
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Catheter site erythema
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Chest discomfort
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Face oedema
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Malaise
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Oedema
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Candida infection
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
66.7%
2/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
2/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
66.7%
4/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
2/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
60.0%
3/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
3/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
2/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
66.7%
2/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
3/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Blood lactate dehydrogenase increased
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
28.6%
2/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Blood creatinine increased
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Lipase increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
28.6%
2/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Amylase decreased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Amylase increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Aspergillus test positive
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Blood bilirubin decreased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Blood creatine phosphokinase decreased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Body temperature increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Lipase decreased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Protein total decreased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Investigations
Troponin I increased
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
3/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
28.6%
2/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
50.0%
2/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
75.0%
3/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
28.6%
2/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
1/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
25.0%
1/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Vascular disorders
Hypertension
|
40.0%
2/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
60.0%
3/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
33.3%
2/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
14.3%
1/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
Vascular disorders
Pallor
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
20.0%
1/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
|
General disorders
Localised oedema
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/7 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/3 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/4 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
16.7%
1/6 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
0.00%
0/5 • From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI can publish after first multi-site publication, or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on the PI is the sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period that is more than 60 but less than or equal to 180 days from the time submitted to sponsor for review. The sponsor can't require changes to the communication and can't extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER