Trial Outcomes & Findings for Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia (NCT NCT02293993)
NCT ID: NCT02293993
Last Updated: 2021-03-05
Results Overview
DLT was defined as any of the following adverse events (AEs) occurring during Course 1 for which there was a reasonable probability or possibility of a causal relationship with the IMP. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. * Nonhematologic toxicity of Grade ≥3, except for (i) nausea, vomiting, or diarrhea of Grade 3 that is controllable by optimal therapy, and (ii) Grade 3 laboratory findings other than serum creatinine, bilirubin, aspartate aminotransferase, or alanine aminotransferase. * Grade 4 thrombocytopenia that was not present at trial entry and that is not resolved within 7 days * Grade 4 neutropenia that was not present at trial entry and that is not resolved within 7 days * Febrile neutropenia (defined as a neutrophil count of \<500/μL accompanied by a fever of ≥38°C) * Any AE that results in a delay of \>4 weeks in starting the next treatment course
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
28 days (Day 1 to Day 29)
Results posted on
2021-03-05
Participant Flow
This trial consisted of a screening period, dose limiting toxicity (DLT) evaluation period (Course 1), and withdrawal examination. Subjects who completed investigational medicinal product (IMP) administration and all observations during the DLT evaluation period, and who did not have any apparent progression of AML, were permitted to be added extended treatment period (Course 2) to continue treatment with IMP following the DLT evaluation period if they wished.
Participant milestones
| Measure |
Cohort 1
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
|---|---|---|---|---|
|
Course 1 (DLT Evaluation Period)
STARTED
|
4
|
6
|
7
|
4
|
|
Course 1 (DLT Evaluation Period)
COMPLETED
|
3
|
6
|
7
|
3
|
|
Course 1 (DLT Evaluation Period)
NOT COMPLETED
|
1
|
0
|
0
|
1
|
|
Course ≥2 (Extended Treatment Period)
STARTED
|
2
|
5
|
6
|
3
|
|
Course ≥2 (Extended Treatment Period)
COMPLETED
|
0
|
0
|
1
|
2
|
|
Course ≥2 (Extended Treatment Period)
NOT COMPLETED
|
2
|
5
|
5
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
|---|---|---|---|---|
|
Course 1 (DLT Evaluation Period)
Clear progression of the primary disease including relapses
|
1
|
0
|
0
|
1
|
|
Course ≥2 (Extended Treatment Period)
Physician Decision
|
0
|
2
|
1
|
0
|
|
Course ≥2 (Extended Treatment Period)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Course ≥2 (Extended Treatment Period)
Clear progression of the primary disease including relapses
|
2
|
2
|
3
|
1
|
|
Course ≥2 (Extended Treatment Period)
Delay in commencement of the next course by more than 4 weeks
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Cohort 1
n=4 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
n=7 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
n=4 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 days (Day 1 to Day 29)Population: DLT analysis population included subjects in whom tolerability had been assessed in Cohorts 1 to 4 (subjects who had received all doses and completed all assessments scheduled for the DLT evaluation period).
DLT was defined as any of the following adverse events (AEs) occurring during Course 1 for which there was a reasonable probability or possibility of a causal relationship with the IMP. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. * Nonhematologic toxicity of Grade ≥3, except for (i) nausea, vomiting, or diarrhea of Grade 3 that is controllable by optimal therapy, and (ii) Grade 3 laboratory findings other than serum creatinine, bilirubin, aspartate aminotransferase, or alanine aminotransferase. * Grade 4 thrombocytopenia that was not present at trial entry and that is not resolved within 7 days * Grade 4 neutropenia that was not present at trial entry and that is not resolved within 7 days * Febrile neutropenia (defined as a neutrophil count of \<500/μL accompanied by a fever of ≥38°C) * Any AE that results in a delay of \>4 weeks in starting the next treatment course
Outcome measures
| Measure |
Cohort 1
n=3 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
n=3 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 1 (Day 5)
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2 (Day 5)
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3 (Day 12)
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4 (Day 5)
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12)Population: Analysis population included subjects whose plasma drug concentrations had been measured.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
n=7 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
n=4 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 1 (Day 5)
n=4 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2 (Day 5)
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3 (Day 12)
n=7 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4 (Day 5)
n=4 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110
SGI-110
|
96.8 ng/mL
Standard Deviation 37.3
|
182 ng/mL
Standard Deviation 59.7
|
140 ng/mL
Standard Deviation 33.1
|
359 ng/mL
Standard Deviation 220
|
142 ng/mL
Standard Deviation 97.4
|
200 ng/mL
Standard Deviation 42.4
|
155 ng/mL
Standard Deviation 58.5
|
328 ng/mL
Standard Deviation 208
|
|
Maximum Plasma Concentration (Cmax) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110
decitabine
|
28.6 ng/mL
Standard Deviation 13.8
|
54.1 ng/mL
Standard Deviation 14.7
|
31.8 ng/mL
Standard Deviation 4.08
|
109 ng/mL
Standard Deviation 50.3
|
38.2 ng/mL
Standard Deviation 34.1
|
67.2 ng/mL
Standard Deviation 13.5
|
44.5 ng/mL
Standard Deviation 15.3
|
95.7 ng/mL
Standard Deviation 37.2
|
SECONDARY outcome
Timeframe: Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12)Population: Analysis population included subjects whose plasma drug concentrations had been measured.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
n=7 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
n=4 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 1 (Day 5)
n=4 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2 (Day 5)
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3 (Day 12)
n=7 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4 (Day 5)
n=4 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110
SGI-110
|
1.49 h
Interval 0.48 to 1.5
|
0.98 h
Interval 0.23 to 1.45
|
1.48 h
Interval 0.53 to 1.98
|
1.51 h
Interval 0.5 to 2.85
|
0.99 h
Interval 0.48 to 1.5
|
0.97 h
Interval 0.52 to 2.0
|
1.42 h
Interval 0.97 to 1.48
|
1.27 h
Interval 0.48 to 3.0
|
|
Time to Maximum Plasma Concentration (Tmax) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110
decitabine
|
2.04 h
Interval 0.48 to 3.02
|
1.27 h
Interval 0.52 to 1.5
|
1.93 h
Interval 1.03 to 2.0
|
1.51 h
Interval 1.02 to 2.85
|
1.49 h
Interval 0.48 to 2.0
|
1.47 h
Interval 0.92 to 2.0
|
1.43 h
Interval 0.97 to 2.02
|
1.53 h
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12)Population: Analysis population included subjects whose plasma drug concentrations had been measured.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
n=7 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
n=4 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 1 (Day 5)
n=4 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2 (Day 5)
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3 (Day 12)
n=7 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4 (Day 5)
n=4 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110
decitabine
|
70.0 ng·h/mL
Standard Deviation 13.4
|
151 ng·h/mL
Standard Deviation 42.7
|
95.7 ng·h/mL
Standard Deviation 11.7
|
248 ng·h/mL
Standard Deviation 39.9
|
67.0 ng·h/mL
Standard Deviation 18.6
|
150 ng·h/mL
Standard Deviation 34.1
|
101 ng·h/mL
Standard Deviation 10.7
|
240 ng·h/mL
Standard Deviation 41.6
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110
SGI-110
|
207 ng·h/mL
Standard Deviation 36.1
|
398 ng·h/mL
Standard Deviation 75.7
|
332 ng·h/mL
Standard Deviation 61.5
|
710 ng·h/mL
Standard Deviation 119
|
206 ng·h/mL
Standard Deviation 11.7
|
410 ng·h/mL
Standard Deviation 57.9
|
311 ng·h/mL
Standard Deviation 87.2
|
581 ng·h/mL
Standard Deviation 124
|
SECONDARY outcome
Timeframe: Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12)Population: Analysis population included subjects whose plasma drug concentrations had been measured.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
n=7 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
n=4 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 1 (Day 5)
n=4 Participants
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2 (Day 5)
n=6 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3 (Day 12)
n=7 Participants
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4 (Day 5)
n=4 Participants
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
|---|---|---|---|---|---|---|---|---|
|
Terminal-phase Elimination Half-life (T1/2,z) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110
SGI-110
|
0.698 h
Standard Deviation 0.393
|
0.833 h
Standard Deviation 0.493
|
0.740 h
Standard Deviation 0.212
|
0.656 h
Standard Deviation 0.155
|
0.599 h
Standard Deviation 0.332
|
0.503 h
Standard Deviation 0.144
|
0.685 h
Standard Deviation 0.341
|
0.623 h
Standard Deviation 0.153
|
|
Terminal-phase Elimination Half-life (T1/2,z) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110
decitabine
|
1.04 h
Standard Deviation 0.467
|
1.12 h
Standard Deviation 0.564
|
1.09 h
Standard Deviation 0.148
|
0.891 h
Standard Deviation 0.0990
|
0.905 h
Standard Deviation 0.385
|
0.821 h
Standard Deviation 0.231
|
1.14 h
Standard Deviation 0.486
|
0.875 h
Standard Deviation 0.107
|
Adverse Events
Cohort 1
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 4
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=4 participants at risk
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
n=6 participants at risk
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
n=7 participants at risk
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
n=4 participants at risk
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
|---|---|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
3/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Malaise
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
Other adverse events
| Measure |
Cohort 1
n=4 participants at risk
SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 2
n=6 participants at risk
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
Cohort 3
n=7 participants at risk
SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
|
Cohort 4
n=4 participants at risk
SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
42.9%
3/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Senile pruritus
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Infection
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Trichophytosis
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
3/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
57.1%
4/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Immune system disorders
Drug hypersensitivity
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
57.1%
4/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
3/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
71.4%
5/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
42.9%
3/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Psychiatric disorders
Sleep disorder due to a general medical condition
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Eye disorders
Blepharitis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Eye disorders
Trichiasis
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
3/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
3/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Renal and urinary disorders
Renal impairment
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Reproductive system and breast disorders
Genital erosion
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Reproductive system and breast disorders
Genital ulceration
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Injection site induration
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
3/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Injection site pain
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Malaise
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Injection site erythema
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Injection site pruritus
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Injection site reaction
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Pain
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Injection site vesicles
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
General disorders
Oedema
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
42.9%
3/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
83.3%
5/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
85.7%
6/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
75.0%
3/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
85.7%
6/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
75.0%
3/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
White blood cell count decreased
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
57.1%
4/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Neutrophil count decreased
|
50.0%
2/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Antithrombin III decreased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
28.6%
2/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Investigations
Prothrombin level decreased
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
14.3%
1/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
33.3%
2/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
16.7%
1/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Wound
|
25.0%
1/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/6 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/7 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
0.00%
0/4 • From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place