Trial Outcomes & Findings for Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate (NCT NCT01523002)
NCT ID: NCT01523002
Last Updated: 2023-12-14
Results Overview
AUC0-t \& AUC0-∞ of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol) Abbreviations: AUC = area under the concentration-time curve; AUC0-t = AUC from Hour 0 to the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was drawn; AUC0-∞ = AUC from Hour 0 to infinity
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10
Results posted on
2023-12-14
Participant Flow
Participant milestones
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
Period 1
STARTED
|
26
|
30
|
|
Period 1
COMPLETED
|
24
|
19
|
|
Period 1
NOT COMPLETED
|
2
|
11
|
|
Period 2
STARTED
|
24
|
19
|
|
Period 2
COMPLETED
|
18
|
13
|
|
Period 2
NOT COMPLETED
|
6
|
6
|
|
Period 3
STARTED
|
18
|
0
|
|
Period 3
COMPLETED
|
14
|
0
|
|
Period 3
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
3
|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 1
Adverse Event
|
0
|
8
|
|
Period 2
Withdrawal by Subject
|
4
|
1
|
|
Period 2
Adverse Event
|
2
|
5
|
|
Period 3
Withdrawal by Subject
|
1
|
0
|
|
Period 3
Adverse Event
|
3
|
0
|
Baseline Characteristics
Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate
Baseline characteristics by cohort
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Re-dosing
n=26 Participants
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for three days followed by a 40 day follow-up period and a study completion evaluation.
Metoprolol and pyronaridine-artesunate: On Day 1, subjects will receive a single oral 100 mg dose of metoprolol tartrate. On Day 8 and Day 9, subjects will receive a once daily oral dose of pyronaridine-artesunate as follows:
55 - \< 65 kg: 3 tablets (180:60 mg pyronaridine:artesunate)
≥ 65 kg: 4 tablets (180:60 mg pyronaridine:artesunate)
On Day 10, a 100 mg dose of metoprolol will be coadministered with pyronaridine-artesunate at the above dose.
On Days 98 - 100, subjects will receive pyronaridine-artesunate once daily at the same dose described above.
|
Arm B: Pyronaridine-artesunate 60-day Re-dosing
n=30 Participants
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
pyronaridine:artesunate: In the first period, subjects will receive 3 days of pyronaridine-artesunate as follows: 55 - \< 65 kg: 3 tablets (180:60 mg pyronaridine:artesunate)
≥ 65 kg: 4 tablets (180:60 mg pyronaridine:artesunate) followed by a 57 day follow-up period. In the second period, subjects will receive 3 days of pyronaridine-artesunate at the dose described above.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
42 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
43 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental/Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body weight
|
74.4 kg
STANDARD_DEVIATION 11.37 • n=5 Participants
|
69.8 kg
STANDARD_DEVIATION 10.15 • n=7 Participants
|
71.9 kg
STANDARD_DEVIATION 10.88 • n=5 Participants
|
|
Height
|
171 cm
STANDARD_DEVIATION 8.2 • n=5 Participants
|
170 cm
STANDARD_DEVIATION 7.4 • n=7 Participants
|
171 cm
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
BMI
|
25.3 kg/m^2
STANDARD_DEVIATION 2.59 • n=5 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 2.67 • n=7 Participants
|
24.6 kg/m^2
STANDARD_DEVIATION 2.68 • n=5 Participants
|
|
CYP2D6 Phenotype
Poor metabolizer
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
CYP2D6 Phenotype
Intermediate metabolizer
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
CYP2D6 Phenotype
Extensive metabolizer
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
CYP2D6 Phenotype
Ultra-Rapid metabolizer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10Population: 26 participants analyzed for Period 1, 22 participants analyzed for Period 2 (22 participants reached D10 for data collection)
AUC0-t \& AUC0-∞ of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol) Abbreviations: AUC = area under the concentration-time curve; AUC0-t = AUC from Hour 0 to the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was drawn; AUC0-∞ = AUC from Hour 0 to infinity
Outcome measures
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
n=26 Participants
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
Period 1 AUC0-t Metoprolol
|
685 ng.h/ml
Geometric Coefficient of Variation 91
|
—
|
|
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
Period 1 AUC0-∞ Metoprolol
|
746 ng.h/ml
Geometric Coefficient of Variation 89
|
—
|
|
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
Period 2 AUC0-t Metoprolol
|
895 ng.h/ml
Geometric Coefficient of Variation 77.0
|
—
|
|
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
Period 2 AUC0-∞ Metoprolol
|
958 ng.h/ml
Geometric Coefficient of Variation 77.3
|
—
|
|
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
Period 1 AUC0-t α-hydroxymetoprolol
|
707 ng.h/ml
Geometric Coefficient of Variation 51.6
|
—
|
|
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
Period 1 AUC0-∞ α-hydroxymetoprolol
|
804 ng.h/ml
Geometric Coefficient of Variation 41.9
|
—
|
|
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
Period 2 AUC0-t α-hydroxymetoprolol
|
601 ng.h/ml
Geometric Coefficient of Variation 72.2
|
—
|
|
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
Period 2 AUC0-∞ α-hydroxymetoprolol
|
739 ng.h/ml
Geometric Coefficient of Variation 49.5
|
—
|
PRIMARY outcome
Timeframe: Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10Population: 26 participants analyzed for Period 1, 22 participants analyzed for Period 2 (22 participants reached D10 for data collection)
tmax of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol) Abbreviations: tmax = time to maximum observed concentration.
Outcome measures
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
n=26 Participants
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax
Period 1 tmax Metoprolol
|
1.5 hours
Interval 0.75 to 3.0
|
—
|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax
Period 2 tmax Metoprolol
|
1.00 hours
Interval 0.75 to 2.02
|
—
|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax
Period 1 tmax α-hydroxymetoprolol
|
1.5 hours
Interval 0.75 to 8.0
|
—
|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax
Period 2 tmax α-hydroxymetoprolol
|
1.5 hours
Interval 0.42 to 6.0
|
—
|
PRIMARY outcome
Timeframe: Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10Population: 26 participants analyzed for Period 1, 22 participants analyzed for Period 2 (22 participants reached D10 for data collection)
t1/2 of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol) Abbreviations: t1/2 = apparent terminal phase half-life
Outcome measures
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
n=26 Participants
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: t1/2
Period 1 t1/2 Metoprolol
|
3.39 hours
Geometric Coefficient of Variation 24.78
|
—
|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: t1/2
Period 2 t1/2 Metoprolol
|
3.28 hours
Geometric Coefficient of Variation 30.3
|
—
|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: t1/2
Period 1 t1/2 α-hydroxymetoprolol
|
7.34 hours
Geometric Coefficient of Variation 30.8
|
—
|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: t1/2
Period 2 t1/2 α-hydroxymetoprolol
|
7.55 hours
Geometric Coefficient of Variation 29.3
|
—
|
PRIMARY outcome
Timeframe: Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10Population: 26 participants analyzed for Period 1, 22 participants analyzed for Period 2 (22 participants reached D10 for data collection)
Cmax of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol) Abbreviations: Cmax = maximum peak observed concentration
Outcome measures
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
n=26 Participants
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Cmax
Period 1 Cmax Metoprolol
|
152.7 hours
Geometric Coefficient of Variation 77.1
|
—
|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Cmax
Period 2 Cmax Metoprolol
|
228.6 hours
Geometric Coefficient of Variation 62.3
|
—
|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Cmax
Period 1 Cmax α-hydroxymetoprolol
|
73.9 hours
Geometric Coefficient of Variation 75.9
|
—
|
|
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Cmax
Period 2 Cmax α-hydroxymetoprolol
|
66.8 hours
Geometric Coefficient of Variation 78.4
|
—
|
PRIMARY outcome
Timeframe: 140 daysTo assess the safety of redosing a 3-day regimen of pyronaridine-artesunate. Grade 1: mild adverse event Grade 2: moderate adverse event Grade 3: severe and undesirable adverse event Grade 4: life threatening adverse event Grade 5: fatal adverse event resulting in death
Outcome measures
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
n=26 Participants
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
n=30 Participants
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
World Health Organization (WHO) Treatment Emergent Adverse Events
Grade 1 toxicity
|
25 participants
|
24 participants
|
|
World Health Organization (WHO) Treatment Emergent Adverse Events
Grade 2 toxicity
|
12 participants
|
17 participants
|
|
World Health Organization (WHO) Treatment Emergent Adverse Events
Grade 3 toxicity
|
2 participants
|
4 participants
|
|
World Health Organization (WHO) Treatment Emergent Adverse Events
Grade 4 toxicity
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 140 daysTo assess the safety of redosing a 3-day regimen of pyronaridine-artesunate
Outcome measures
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
n=26 Participants
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
n=30 Participants
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
Non-WHO Listed Treatment Emergent Adverse Events
Life-threatening
|
0 participants
|
0 participants
|
|
Non-WHO Listed Treatment Emergent Adverse Events
Mild
|
23 participants
|
21 participants
|
|
Non-WHO Listed Treatment Emergent Adverse Events
Moderate
|
5 participants
|
14 participants
|
|
Non-WHO Listed Treatment Emergent Adverse Events
Severe
|
0 participants
|
0 participants
|
Adverse Events
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Arm B: Pyronaridine-artesunate 60-day Redosing
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
n=26 participants at risk
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for three days followed by a 40 day follow-up period and a study completion evaluation.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
n=30 participants at risk
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Exanthema (rash)
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Musculoskeletal and connective tissue disorders
Discus hernia (intervertebral disc protrusion)
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
Other adverse events
| Measure |
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing
n=26 participants at risk
Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for three days followed by a 40 day follow-up period and a study completion evaluation.
|
Arm B: Pyronaridine-artesunate 60-day Redosing
n=30 participants at risk
Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
76.9%
20/26 • Number of events 66 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
60.0%
18/30 • Number of events 58 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
12/26 • Number of events 18 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
36.7%
11/30 • Number of events 13 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
19.2%
5/26 • Number of events 5 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
30.0%
9/30 • Number of events 12 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
6/26 • Number of events 10 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
20.0%
6/30 • Number of events 10 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Gastrointestinal disorders
Abdominal pain discomfort
|
11.5%
3/26 • Number of events 5 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
10.0%
3/30 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.4%
4/26 • Number of events 5 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
6.7%
2/30 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
11.5%
3/26 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
10.0%
3/30 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
1/26 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
13/26 • Number of events 17 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
53.3%
16/30 • Number of events 22 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
8/26 • Number of events 9 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
56.7%
17/30 • Number of events 20 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
19.2%
5/26 • Number of events 7 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
46.7%
14/30 • Number of events 17 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Investigations
Neutrophil count decreased
|
7.7%
2/26 • Number of events 5 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
10.0%
3/30 • Number of events 7 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
2/26 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
10.0%
3/30 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Investigations
Blood bilirubin increased
|
7.7%
2/26 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Investigations
Prothrombin time prolonged
|
7.7%
2/26 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Investigations
White blood cell count decreased
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Investigations
Platelet count increased
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Nervous system disorders
Headache
|
57.7%
15/26 • Number of events 33 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
53.3%
16/30 • Number of events 24 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Nervous system disorders
Dizziness
|
34.6%
9/26 • Number of events 11 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
20.0%
6/30 • Number of events 7 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Fatigue
|
38.5%
10/26 • Number of events 13 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
16.7%
5/30 • Number of events 6 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Chills
|
3.8%
1/26 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
6.7%
2/30 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Malaise
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Pyrexia
|
7.7%
2/26 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Chest discomfort
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Feeling hot
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Inflammation
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Injection site pain
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Vessel puncture site
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
General disorders
Swelling
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
4/26 • Number of events 5 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
23.3%
7/30 • Number of events 8 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
20.0%
6/30 • Number of events 6 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
6.7%
2/30 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Infections and infestations
Nasopharngitis
|
11.5%
3/26 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
20.0%
6/30 • Number of events 6 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Infections and infestations
Rhinitis
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
6.7%
2/30 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
13.3%
4/30 • Number of events 4 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
2/26 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
2/26 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
10.0%
3/30 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
6.7%
2/30 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Renal and urinary disorders
Proteinuria
|
19.2%
5/26 • Number of events 5 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
10.0%
3/30 • Number of events 3 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Injury, poisoning and procedural complications
Scratch
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Vascular disorders
Hot flush
|
7.7%
2/26 • Number of events 2 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Surgical and medical procedures
Surgery
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Surgical and medical procedures
Tooth repair
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Eye disorders
Eye irritation
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
0.00%
0/30 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/26 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
3.3%
1/30 • Number of events 1 • Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
|
Additional Information
Stephan Duparc, MD, Chief Medical Officer
Medicines for Malaria Venture (MMV)
Phone: +41 22 555 0300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place