Trial Outcomes & Findings for Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria. (NCT NCT03334747)
NCT ID: NCT03334747
Last Updated: 2021-10-11
Results Overview
The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
188 participants
Primary outcome timeframe
Day 29
Results posted on
2021-10-11
Participant Flow
This study was conducted in 10 centers in 5 countries: Mali (2), Uganda (3), Ghana (2), Gabon (1), Rwanda (2).
Approximately, 210 patients were planned to be randomized in six cohorts (KAE609: 150 and Coartem: 60). A total of 188 (KAE609: 137 and Coartem: 51) subjects were randomized in five cohorts. Cohort 6 was optional and never initiated. Two of the 188 randomized subjects were not treated and therefore were excluded from all analyses.
Participant milestones
| Measure |
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Treatment Phase
STARTED
|
10
|
10
|
12
|
20
|
22
|
20
|
21
|
22
|
51
|
|
Treatment Phase
COMPLETED
|
9
|
10
|
12
|
20
|
21
|
19
|
21
|
22
|
51
|
|
Treatment Phase
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Follow-Up Phase
STARTED
|
9
|
10
|
12
|
20
|
21
|
19
|
21
|
22
|
51
|
|
Follow-Up Phase
COMPLETED
|
9
|
10
|
12
|
20
|
21
|
19
|
20
|
22
|
50
|
|
Follow-Up Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Treatment Phase
Technical problems
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Phase
Subject/guardian decision
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Follow-Up Phase
Subject/guardian decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
Baseline characteristics by cohort
| Measure |
KAE609 10 mg SD
n=10 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=22 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=20 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=21 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
n=51 Participants
control arm
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.5 Years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
35.4 Years
STANDARD_DEVIATION 13.25 • n=7 Participants
|
33.0 Years
STANDARD_DEVIATION 14.96 • n=5 Participants
|
31.9 Years
STANDARD_DEVIATION 10.67 • n=4 Participants
|
33.9 Years
STANDARD_DEVIATION 12.56 • n=21 Participants
|
26.4 Years
STANDARD_DEVIATION 7.18 • n=8 Participants
|
28.2 Years
STANDARD_DEVIATION 10.25 • n=8 Participants
|
30.6 Years
STANDARD_DEVIATION 12.57 • n=24 Participants
|
26.2 Years
STANDARD_DEVIATION 9.07 • n=42 Participants
|
29.7 Years
STANDARD_DEVIATION 11.07 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
73 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
115 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
51 Participants
n=42 Participants
|
188 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Safety Set (SAF). Only participants with baseline and at least one post-baseline assessment for either ALT or AST are included in the analysis.
The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.
Outcome measures
| Measure |
KAE609 10 mg SD
n=9 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=21 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=19 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=21 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
n=51 Participants
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)
|
11.1 Percentage of Participants
Interval 0.3 to 48.2
|
0 Percentage of Participants
Interval 0.0 to 30.8
|
0 Percentage of Participants
Interval 0.0 to 26.5
|
0 Percentage of Participants
Interval 0.0 to 16.8
|
0 Percentage of Participants
Interval 0.0 to 16.1
|
0 Percentage of Participants
Interval 0.0 to 17.6
|
0 Percentage of Participants
Interval 0.0 to 16.1
|
4.5 Percentage of Participants
Interval 0.1 to 22.8
|
3.9 Percentage of Participants
Interval 0.5 to 13.5
|
SECONDARY outcome
Timeframe: Day 15, Day 29Population: Full Analysis Set (FAS). Only responders at each timepoint are included in the analysis.
PCR-corrected and PCR-uncorrected were evaluated at Days 15 and 29 (i.e., 14 and 28 days post-dose). The presence of parasitaemia after 7 days due to reinfection was considered as PCR-corrected ACPR. Missing blood smear data at Day 15 visit and thereafter were not considered as responder for the visit unless there was a later blood smear test indicating no parasitaemia.
Outcome measures
| Measure |
KAE609 10 mg SD
n=10 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=21 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=19 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=21 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
n=51 Participants
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
Day 15: PCR corrected
|
90.0 Percentage of Participants
Interval 55.5 to 99.75
|
90.0 Percentage of Participants
Interval 55.5 to 99.75
|
83.3 Percentage of Participants
Interval 51.59 to 97.91
|
95.0 Percentage of Participants
Interval 75.13 to 99.87
|
95.2 Percentage of Participants
Interval 76.18 to 99.88
|
84.2 Percentage of Participants
Interval 60.42 to 96.62
|
90.5 Percentage of Participants
Interval 69.62 to 98.83
|
77.3 Percentage of Participants
Interval 54.63 to 92.18
|
96.1 Percentage of Participants
Interval 86.54 to 99.52
|
|
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
Day 15: PCR uncorrected
|
90.0 Percentage of Participants
Interval 55.5 to 99.75
|
90.0 Percentage of Participants
Interval 55.5 to 99.75
|
83.3 Percentage of Participants
Interval 51.59 to 97.91
|
95.0 Percentage of Participants
Interval 75.13 to 99.87
|
95.2 Percentage of Participants
Interval 76.18 to 99.88
|
84.2 Percentage of Participants
Interval 60.42 to 96.62
|
85.7 Percentage of Participants
Interval 63.66 to 96.95
|
77.3 Percentage of Participants
Interval 54.63 to 92.18
|
96.1 Percentage of Participants
Interval 86.54 to 99.52
|
|
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
Day 29: PCR corrected
|
80.0 Percentage of Participants
Interval 44.39 to 97.48
|
90.0 Percentage of Participants
Interval 55.5 to 99.75
|
83.3 Percentage of Participants
Interval 51.59 to 97.91
|
90.0 Percentage of Participants
Interval 68.3 to 98.77
|
85.7 Percentage of Participants
Interval 63.66 to 96.95
|
73.7 Percentage of Participants
Interval 48.8 to 90.85
|
81.0 Percentage of Participants
Interval 58.09 to 94.55
|
68.2 Percentage of Participants
Interval 45.13 to 86.14
|
94.1 Percentage of Participants
Interval 83.76 to 98.77
|
|
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
Day 29: PCR uncorrected
|
80.0 Percentage of Participants
Interval 44.39 to 97.48
|
90.0 Percentage of Participants
Interval 55.5 to 99.75
|
66.7 Percentage of Participants
Interval 34.89 to 90.08
|
80.0 Percentage of Participants
Interval 56.34 to 94.27
|
81.0 Percentage of Participants
Interval 58.09 to 94.55
|
68.4 Percentage of Participants
Interval 43.45 to 87.42
|
71.4 Percentage of Participants
Interval 47.82 to 88.72
|
59.1 Percentage of Participants
Interval 36.35 to 79.29
|
92.2 Percentage of Participants
Interval 81.12 to 97.82
|
SECONDARY outcome
Timeframe: Day 29Population: Full Analysis Set (FAS). Only participants with parasite at baseline and post-baseline assessment of parasite clearance at the time point are included in the analysis.
Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a patient received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.
Outcome measures
| Measure |
KAE609 10 mg SD
n=10 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=21 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=19 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=21 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
n=51 Participants
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Parasite Clearance Time (PCT)
|
26.8 Hours
Standard Error 5.44
|
27.7 Hours
Standard Error 4.96
|
14.0 Hours
Standard Error 2.63
|
11.4 Hours
Standard Error 1.82
|
11.1 Hours
Standard Error 1.58
|
9.8 Hours
Standard Error 0.97
|
8.7 Hours
Standard Error 0.97
|
8.0 Hours
Standard Error 1.09
|
36.2 Hours
Standard Error 3.72
|
SECONDARY outcome
Timeframe: Day 29Population: Full Analysis Set (FAS). Only participants with fever at baseline and post-baseline assessment of fever clearance at the time point are included in the analysis.
Fever Clearance Time (FCT) is defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. In case a patient received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.
Outcome measures
| Measure |
KAE609 10 mg SD
n=10 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=21 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=19 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=21 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
n=51 Participants
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Fever Clearance Time (FCT)
|
3.9 Hours
Standard Error NA
NA: Not Estimable due to number of events censored
|
2.0 Hours
Standard Error 0.02
|
NA Hours
Standard Error NA
NA: Not Estimable due to number of events censored
|
22.0 Hours
Standard Error 14.03
|
2.4 Hours
Standard Error 0.93
|
7.2 Hours
Standard Error 1.47
|
5.7 Hours
Standard Error 2.02
|
9.9 Hours
Standard Error 3.88
|
13.0 Hours
Standard Error 4.29
|
SECONDARY outcome
Timeframe: Day 29Population: Full Analysis Set (FAS). Only participants with clearance of initial infection before Day 15 and recrudescence/reinfection are included in the analysis.
Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured.
Outcome measures
| Measure |
KAE609 10 mg SD
n=8 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=21 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=19 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=21 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
n=51 Participants
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Recrudescence and Reinfection at Study Day 29
Recrudescence
|
12.5 Event probability
Interval 1.86 to 61.3
|
10.0 Event probability
Interval 1.47 to 52.7
|
16.7 Event probability
Interval 4.45 to 51.83
|
10.0 Event probability
Interval 2.6 to 34.4
|
16.0 Event probability
Interval 5.42 to 41.93
|
26.3 Event probability
Interval 11.9 to 52.11
|
15.9 Event probability
Interval 5.4 to 41.67
|
32.5 Event probability
Interval 16.93 to 56.43
|
2.4 Event probability
Interval 0.34 to 15.72
|
|
Time to Recrudescence and Reinfection at Study Day 29
Reinfection
|
—
|
—
|
25.0 Event probability
Interval 6.91 to 68.52
|
14.3 Event probability
Interval 3.78 to 46.06
|
5.0 Event probability
Interval 0.72 to 30.53
|
10.0 Event probability
Interval 1.47 to 52.7
|
10.3 Event probability
Interval 2.67 to 35.25
|
13.3 Event probability
Interval 3.51 to 43.61
|
2.4 Event probability
Interval 0.34 to 15.72
|
SECONDARY outcome
Timeframe: Day 1, Day 3Population: PK Analysis Set
Maximum Peak Observed Concentration (Cmax)
Outcome measures
| Measure |
KAE609 10 mg SD
n=9 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=21 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=19 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=20 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Peak Observed Concentration (Cmax)
Day 1
|
179 ng/mL
Geometric Coefficient of Variation 38.2
|
185 ng/mL
Geometric Coefficient of Variation 51.2
|
379 ng/mL
Geometric Coefficient of Variation 42.1
|
503 ng/mL
Geometric Coefficient of Variation 44.3
|
773 ng/mL
Geometric Coefficient of Variation 32.4
|
828 ng/mL
Geometric Coefficient of Variation 35.4
|
1270 ng/mL
Geometric Coefficient of Variation 41.3
|
2360 ng/mL
Geometric Coefficient of Variation 28.5
|
—
|
|
Maximum Peak Observed Concentration (Cmax)
Day 3
|
—
|
235 ng/mL
Geometric Coefficient of Variation 37.0
|
—
|
655 ng/mL
Geometric Coefficient of Variation 27.9
|
—
|
1210 ng/mL
Geometric Coefficient of Variation 30.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 3Population: PK Analysis Set
Tmax
Outcome measures
| Measure |
KAE609 10 mg SD
n=9 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=21 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=19 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=20 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Tmax
Day 3
|
—
|
52.7 Hour
Interval 50.0 to 60.6
|
—
|
52.1 Hour
Interval 49.9 to 59.6
|
—
|
52.0 Hour
Interval 50.0 to 60.5
|
—
|
—
|
—
|
|
Tmax
Day 1
|
4.00 Hour
Interval 1.02 to 12.1
|
3.92 Hour
Interval 1.03 to 6.17
|
4.01 Hour
Interval 2.0 to 8.33
|
4.25 Hour
Interval 2.0 to 23.8
|
4.12 Hour
Interval 1.97 to 10.0
|
4.12 Hour
Interval 2.0 to 6.13
|
6.01 Hour
Interval 3.97 to 12.3
|
8.07 Hour
Interval 1.0 to 24.1
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 3Population: PK Analysis Set
AUC0-24
Outcome measures
| Measure |
KAE609 10 mg SD
n=9 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=21 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=19 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=20 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC0-24
Day 1
|
2.77 h*ug/mL
Geometric Coefficient of Variation 48.9
|
2.59 h*ug/mL
Geometric Coefficient of Variation 38.0
|
5.14 h*ug/mL
Geometric Coefficient of Variation 52.5
|
8.39 h*ug/mL
Geometric Coefficient of Variation 45.1
|
11.6 h*ug/mL
Geometric Coefficient of Variation 37.7
|
15.6 h*ug/mL
Geometric Coefficient of Variation 27.2
|
21.4 h*ug/mL
Geometric Coefficient of Variation 41.5
|
40.4 h*ug/mL
Geometric Coefficient of Variation 26.6
|
—
|
|
AUC0-24
Day 3
|
—
|
3.90 h*ug/mL
Geometric Coefficient of Variation 38.5
|
—
|
10.9 h*ug/mL
Geometric Coefficient of Variation 29.7
|
—
|
21.6 h*ug/mL
Geometric Coefficient of Variation 31.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Upto day 15 post dosePopulation: PK Analysis Set
Half-life (T\^1/2)
Outcome measures
| Measure |
KAE609 10 mg SD
n=9 Participants
KAE609 10 mg once daily (QD) for 1 day
|
KAE609 10 mg QD 3 Days
n=10 Participants
KAE609 10 mg (QD) for 3 days
|
KAE609 25 mg SD
n=12 Participants
KAE609 25 mg once daily (QD) for 1 day
|
KAE609 25 mg QD 3 Days
n=20 Participants
KAE609 25 mg once daily (QD) for 3 days
|
KAE609 50 mg SD
n=21 Participants
KAE609 50 mg once daily (QD) for 1 day
|
KAE609 50 mg QD 3 Days
n=19 Participants
KAE609 50 mg once daily (QD) for 3 days
|
KAE609 75 mg SD
n=20 Participants
KAE609 75 mg once daily (QD) for 1 day
|
KAE609 150 mg SD
n=22 Participants
KAE609 150 mg once daily (QD) for 1 day
|
Pooled Coartem Control
control arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Half-life (T^1/2)
Day 1
|
24.4 Hour
Standard Deviation 8.70
|
18.5 Hour
Standard Deviation 6.24
|
35.1 Hour
Standard Deviation 13.9
|
17.4 Hour
Standard Deviation 3.27
|
31.5 Hour
Standard Deviation 17.4
|
32.8 Hour
Standard Deviation 5.05
|
25.3 Hour
Standard Deviation 8.94
|
29.9 Hour
Standard Deviation 12.5
|
—
|
|
Half-life (T^1/2)
Day 3
|
—
|
32.4 Hour
Standard Deviation 14.8
|
—
|
30.1 Hour
Standard Deviation 14.0
|
—
|
29.9 Hour
Standard Deviation 22.0
|
—
|
—
|
—
|
Adverse Events
KAE609 10mg SD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
KAE609 10mg QD@3 Days
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
KAE609 25mg SD
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
KAE609 25mg QD@3 Days
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
KAE609 50mg SD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
KAE609 50mg QD@3 Days
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
KAE609 75mg SD
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
KAE609 150mg SD
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Pooled Coartem
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KAE609 10mg SD
n=10 participants at risk
KAE609 10mg SD
|
KAE609 10mg QD@3 Days
n=10 participants at risk
KAE609 10mg QD@3 days
|
KAE609 25mg SD
n=12 participants at risk
KAE609 25mg SD
|
KAE609 25mg QD@3 Days
n=20 participants at risk
KAE609 25mg QD@3 days
|
KAE609 50mg SD
n=21 participants at risk
KAE609 50mg SD
|
KAE609 50mg QD@3 Days
n=19 participants at risk
KAE609 50mg QD@3 days
|
KAE609 75mg SD
n=21 participants at risk
KAE609 75mg SD
|
KAE609 150mg SD
n=22 participants at risk
KAE609 150mg SD
|
Pooled Coartem
n=51 participants at risk
Pooled Coartem
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.5%
1/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
2.0%
1/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
Other adverse events
| Measure |
KAE609 10mg SD
n=10 participants at risk
KAE609 10mg SD
|
KAE609 10mg QD@3 Days
n=10 participants at risk
KAE609 10mg QD@3 days
|
KAE609 25mg SD
n=12 participants at risk
KAE609 25mg SD
|
KAE609 25mg QD@3 Days
n=20 participants at risk
KAE609 25mg QD@3 days
|
KAE609 50mg SD
n=21 participants at risk
KAE609 50mg SD
|
KAE609 50mg QD@3 Days
n=19 participants at risk
KAE609 50mg QD@3 days
|
KAE609 75mg SD
n=21 participants at risk
KAE609 75mg SD
|
KAE609 150mg SD
n=22 participants at risk
KAE609 150mg SD
|
Pooled Coartem
n=51 participants at risk
Pooled Coartem
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.5%
1/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.9%
3/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.5%
1/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.9%
3/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
2.0%
1/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
8.3%
1/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.9%
3/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
General disorders
Asthenia
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
9.5%
2/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
General disorders
Pain
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
8.3%
1/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
3.9%
2/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
General disorders
Treatment failure
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
25.0%
3/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
3.9%
2/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
3.9%
2/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
15.8%
3/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
9.5%
2/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
13.6%
3/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
3.9%
2/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Infections and infestations
Malaria
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
16.7%
2/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
20.0%
4/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
19.0%
4/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
26.3%
5/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
23.8%
5/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
40.9%
9/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
2.0%
1/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
8.3%
1/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.5%
1/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.9%
3/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.9%
3/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Investigations
Bacterial test positive
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
2.0%
1/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.5%
1/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
9.5%
2/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
8.3%
1/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
8.3%
1/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
8.3%
1/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
2.0%
1/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
50.0%
5/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
8.3%
1/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
9.5%
2/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.5%
2/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
23.8%
5/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
17.6%
9/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
8.3%
1/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
10.5%
2/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
2.0%
1/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.5%
1/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.3%
1/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
5.0%
1/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
4.8%
1/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
2.0%
1/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/10 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
8.3%
1/12 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/20 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/19 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/21 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/22 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
0.00%
0/51 • All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER