Trial Outcomes & Findings for A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies (NCT NCT01957579)
NCT ID: NCT01957579
Last Updated: 2017-06-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
From baseline to 30 days after the last dose of study drug
Results posted on
2017-06-12
Participant Flow
First patient enrolled on 25 May 2011. Last patient last visit on 15 September 2015.
A total of 32 patients were enrolled into the study. Twelve patients were screen failures, thus 20 patients received MEDI-551.
Participant milestones
| Measure |
2 mg/kg
MEDI-551 2 mg/kg
|
4 mg/kg
MEDI-551 4 mg/kg
|
8 mg/kg
MEDI-551 8 mg/kg
|
12 mg/kg
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
4
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
2 mg/kg
MEDI-551 2 mg/kg
|
4 mg/kg
MEDI-551 4 mg/kg
|
8 mg/kg
MEDI-551 8 mg/kg
|
12 mg/kg
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Overall Study
Withdrawal of concent
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
Baseline characteristics by cohort
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2mg/kg
|
4 mg/kg
n=7 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=4 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=6 Participants
MEDI-551 12 mg/kg
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.3 Years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
57.4 Years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
67.0 Years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
67.3 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
61.3 Years
STANDARD_DEVIATION 11.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Disease Type
CLL
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Disease Type
DLBCL
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Disease Type
FL
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Disease Type
MM
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From baseline to 30 days after the last dose of study drugPopulation: All patients who received at least 1 dose of MEDI-551.
Outcome measures
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=7 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=4 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=6 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
At least 1 AE of CTCAE Grade 3 or higher
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
At least 1 Adverse Events (AE)
|
3 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events
At least 1 Serious Adverse Events (SAE)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to 28 days after the first dose of study drugPopulation: All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.
A MEDI-551 treatment-related AE of any toxicity grade that lead to an inability to receive a full cycle (2 doses) of MEDI-551, or, any Grade 3 or higher toxicity that could not be reasonably ascribed to another cause, such as disease progression or accident.
Outcome measures
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=6 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=3 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=6 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
At least 1 Dose Limiting Toxicity
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Dose Limiting Toxicities
CTCAE Grade 3 or higher non-hematologic toxicity
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Dose Limiting Toxicities
CTCAE Grade 3 or higher hematologic toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline to 28 days after the first dose of study drugPopulation: All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.
A dose was considered non-tolerated and dose escalation stopped if ≥2 of up to 6 evaluable patients experienced a DLT at any dose level. MTD is the last dose level before the non-tolerated dose.
Outcome measures
| Measure |
2 mg/kg
n=18 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
MEDI-551 4 mg/kg
|
8 mg/kg
MEDI-551 8 mg/kg
|
12 mg/kg
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Maximum Tolerated Dose
|
8 mg/kg
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-dose)Population: Patients who have trough concentration data at Day 0 (pre-dose)
Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Outcome measures
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=7 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=4 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=6 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose)
|
NA μg/mL
Standard Deviation NA
Below limit of quantification
|
NA μg/mL
Standard Deviation NA
Below limit of quantification
|
NA μg/mL
Standard Deviation NA
Below limit of quantification
|
NA μg/mL
Standard Deviation NA
Below limit of quantification
|
SECONDARY outcome
Timeframe: Day 7Population: Patients who have trough concentration data at Day 7
Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Outcome measures
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=6 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=4 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=4 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
MEDI-551 Trough Concentration Levels at Day 7
|
21.3 μg/mL
Standard Deviation 8.65
|
39.2 μg/mL
Standard Deviation 9.13
|
91.9 μg/mL
Standard Deviation 31.1
|
104 μg/mL
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: Day 28Population: Patients who have trough concentration data at Day 28
Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Outcome measures
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=5 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=3 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=4 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
MEDI-551 Trough Concentration Levels at Day 28
|
23.2 μg/mL
Standard Deviation 5.82
|
36.2 μg/mL
Standard Deviation 5.34
|
103 μg/mL
Standard Deviation 29.0
|
115 μg/mL
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: Day 56Population: Patients who have trough concentration data at Day 56
Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Outcome measures
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=5 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=3 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=4 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
MEDI-551 Trough Concentration Levels at Day 56
|
22.0 μg/mL
Standard Deviation 4.92
|
33.2 μg/mL
Standard Deviation 6.92
|
89.5 μg/mL
Standard Deviation 13.9
|
114 μg/mL
Standard Deviation 33.1
|
SECONDARY outcome
Timeframe: Day 84Population: Patients who have trough concentration data at Day 84
Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Outcome measures
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=4 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=3 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=4 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
MEDI-551 Trough Concentration Levels at Day84
|
21.7 μg/mL
Standard Deviation 4.40
|
33.7 μg/mL
Standard Deviation 4.24
|
91.6 μg/mL
Standard Deviation 9.25
|
103 μg/mL
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: Day 112Population: Patients who have trough concentration data at Day 112
Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Outcome measures
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=4 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=2 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=4 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
MEDI-551 Trough Concentration Levels at Day 112
|
22.9 μg/mL
Standard Deviation 3.10
|
35.3 μg/mL
Standard Deviation 5.07
|
85.5 μg/mL
Standard Deviation NA
Standard Deviation was calculated only if n\>=3.
|
114 μg/mL
Standard Deviation 64.4
|
SECONDARY outcome
Timeframe: Day 140Population: Patients who have trough concentration data at Day 140
Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Outcome measures
| Measure |
2 mg/kg
n=2 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=4 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=2 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=4 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
MEDI-551 Trough Concentration Levels at Day 140
|
22.1 μg/mL
Standard Deviation NA
Standard Deviation was calculated only if n\>=3.
|
36.3 μg/mL
Standard Deviation 10.5
|
86.1 μg/mL
Standard Deviation NA
Standard Deviation was calculated only if n\>=3.
|
117 μg/mL
Standard Deviation 62.0
|
SECONDARY outcome
Timeframe: Day 168Population: Patients who have trough concentration data at Day 168
Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Outcome measures
| Measure |
2 mg/kg
n=2 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=3 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=2 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=2 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
MEDI-551 Trough Concentration Levels at Day 168
|
20.0 μg/mL
Standard Deviation NA
Standard Deviation was calculated only if n\>=3.
|
31.4 μg/mL
Standard Deviation 8.30
|
94.1 μg/mL
Standard Deviation NA
Standard Deviation was calculated only if n\>=3.
|
82.1 μg/mL
Standard Deviation NA
Standard Deviation was calculated only if n\>=3.
|
SECONDARY outcome
Timeframe: From baseline to 30 days after the last dose of study drugPopulation: Patients who have at least one post-baseline sample for Anti-MEDI-551 antibodies.
Only 1 patient was tested positive for ADA at pre-dose of Cycle 1 Day 1. However, it was considered as false-positive because the titer value was close to the cut point, and this patient was tested negative for ADA at all subsequent cycles post-baseline.
Outcome measures
| Measure |
2 mg/kg
n=3 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=7 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=4 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=6 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Anti-MEDI-551 Antibodies
positive at least 1 time point
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Anti-MEDI-551 Antibodies
negative at all time points
|
3 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From the baseline to 30 days after the last dose of study drugPopulation: All patients with FL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.
Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007). CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified.
Outcome measures
| Measure |
2 mg/kg
n=2 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
n=4 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=2 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=3 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Number of Participants With Tumour Response in FL Patients
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the baseline to 30 days after the last dose of study drugPopulation: All patients with DLBCL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.
Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007). CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified.
Outcome measures
| Measure |
2 mg/kg
MEDI-551 2 mg/kg
|
4 mg/kg
n=2 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
n=2 Participants
MEDI-551 8 mg/kg
|
12 mg/kg
n=2 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Number of Participants With Tumour Response in DLBCL Patients
|
—
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the baseline to 30 days after the last dose of study drugPopulation: All patients with CLL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.
Tumour response is defined as complete remission (CR) or partial remission (PR) (Hallek M et al 2008). CR: all of the following criteria have to be met, and patients have to lack disease-related constitutional symptoms; Lymphadenopathy: None; Hepatomegaly: None; Splenomegaly: None; Blood lymphocytes: \<4000/μL; Marrow: Normocellular, \<30%lymphocytes, no B-lymphoid nodules, hypocellular marrow defines CR with incomplete marrow recovery; Platelet count: \>100000/μL; Hemoglobin: \>11.0 g/dL; Neutrophils: \>1500/μL PR: at least 2 of the criteria of group A plus 1 of the criteria of group B have to be met. Group A: Lymphadenopathy: Decrease ≥50%; Hepatomegaly: Decrease ≥50%; Splenomegaly: Decrease ≥50%; Blood lymphocytes: Decrease ≥50% from baseline; Marrow: 50% reduction in marrow infiltrate, or B-lymphoid nodules. Group B: Platelet count: 100000/μL or increase ≥50% over baseline; Hemoglobin: \>11.0 g/dL or increase ≥50% over baseline; Neutrophils: \>1500/μL or \>50% improvement over baseline.
Outcome measures
| Measure |
2 mg/kg
n=1 Participants
MEDI-551 2 mg/kg
|
4 mg/kg
MEDI-551 4 mg/kg
|
8 mg/kg
MEDI-551 8 mg/kg
|
12 mg/kg
n=1 Participants
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Number of Participants With Tumour Response in CLL Patients
|
1 Participants
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: From the baseline to30 days after the last dose of study drugPopulation: All patients with MM who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.
Tumour response is defined as complete response (CR) or partial response (PR) (Durie M et al 2006). CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200mg per 24 h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition to the above listed criteria, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required.
Outcome measures
| Measure |
2 mg/kg
MEDI-551 2 mg/kg
|
4 mg/kg
n=1 Participants
MEDI-551 4 mg/kg
|
8 mg/kg
MEDI-551 8 mg/kg
|
12 mg/kg
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Number of Participants With Tumour Response in MM Patients
|
—
|
0 Participants
|
—
|
—
|
Adverse Events
2 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
4 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
8 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
12 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 mg/kg
n=3 participants at risk
MEDI-551 2mg/kg
|
4 mg/kg
n=7 participants at risk
MEDI-551 4 mg/kg
|
8 mg/kg
n=4 participants at risk
MEDI-551 8 mg/kg
|
12 mg/kg
n=6 participants at risk
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Infections and infestations
Epiglottitis
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
Other adverse events
| Measure |
2 mg/kg
n=3 participants at risk
MEDI-551 2mg/kg
|
4 mg/kg
n=7 participants at risk
MEDI-551 4 mg/kg
|
8 mg/kg
n=4 participants at risk
MEDI-551 8 mg/kg
|
12 mg/kg
n=6 participants at risk
MEDI-551 12 mg/kg
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
66.7%
2/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
75.0%
3/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
50.0%
3/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
White blood cell count decreased
|
66.7%
2/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
28.6%
2/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
28.6%
2/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
28.6%
2/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Investigations
Blood triglycerides increased
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
100.0%
4/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
General disorders
Fatigue
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
28.6%
2/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sebaceous adenoma
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
14.3%
1/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
28.6%
2/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
16.7%
1/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Renal and urinary disorders
Calculus ureteric
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/7 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/4 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
0.00%
0/6 • AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place