Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults (NCT NCT01290601)
NCT ID: NCT01290601
Last Updated: 2018-02-23
Results Overview
A subject will be considered a success (cure) if they have an Adequate Clinical Response (ACR). Tafenoquine was efficacious if the lower bound of the two-sided 90% confidence interval for the day 28 cure rate was not less than 85%
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
28 Days
Results posted on
2018-02-23
Participant Flow
70 subjects were randomized and hospitalized at the Bangkok Hospital for Tropical Diseases for the first 29 days of the study and asked to remain in a malaria non-endemic area until 90 days after study start. Subs had f/u's at D60 and D90, and were contacted at D120 for follow-up blood smear. Subjects remained in the study for 121 days.
During the IDMC review it was determined that Cohort 1 failed to meet the pre-specified endpoint for the day 28 cure rate and therefore Cohort 2 should not be initiated and follow-up in Cohort 1 should be completed according to protocol. Following last subject last visit for Cohort 1 the study was terminated.
Participant milestones
| Measure |
Cohort 1 Tafenoquine
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
Cohort 2 Tafenoquine
Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.
tafenoquine: Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.
|
Cohort 2 Chloroquine
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
24
|
0
|
0
|
|
Overall Study
COMPLETED
|
35
|
19
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Tafenoquine
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
Cohort 2 Tafenoquine
Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.
tafenoquine: Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.
|
Cohort 2 Chloroquine
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
2
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults
Baseline characteristics by cohort
| Measure |
Cohort 1 Tafenoquine
n=46 Participants
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
n=24 Participants
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.5 years
STANDARD_DEVIATION 6.37 • n=93 Participants
|
29.7 years
STANDARD_DEVIATION 8.57 • n=4 Participants
|
29.7 years
STANDARD_DEVIATION 8.57 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
46 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Region of Enrollment
Thailand
|
46 participants
n=93 Participants
|
24 participants
n=4 Participants
|
70 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: Intent to treat population
A subject will be considered a success (cure) if they have an Adequate Clinical Response (ACR). Tafenoquine was efficacious if the lower bound of the two-sided 90% confidence interval for the day 28 cure rate was not less than 85%
Outcome measures
| Measure |
Cohort 1 Tafenoquine
n=46 Participants
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
n=24 Participants
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
|---|---|---|
|
Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate
Adequate Clinical Response (ACR)
|
40 Participants
|
22 Participants
|
|
Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate
Early Treatment Failure
|
5 Participants
|
0 Participants
|
|
Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate
Late Treatment Failure
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 28, Months 2, 3 and 4Population: Intent to treat population
Number of subjects without relapse of P. vivax at 2, 3 and 4 months \- Blood smears were obtained at Days 28, 60, 90 and 120 to confirm the continued absence of P. vivax parasitemia
Outcome measures
| Measure |
Cohort 1 Tafenoquine
n=46 Participants
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
n=24 Participants
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
|---|---|---|
|
Number of Subjects Without Relapse of P. Vivax
Cleared at Day 28
|
40 participants
|
22 participants
|
|
Number of Subjects Without Relapse of P. Vivax
Relapsed by Day 60
|
0 participants
|
0 participants
|
|
Number of Subjects Without Relapse of P. Vivax
Relapsed by Day 90
|
0 participants
|
1 participants
|
|
Number of Subjects Without Relapse of P. Vivax
Relapsed by Day 120
|
0 participants
|
1 participants
|
|
Number of Subjects Without Relapse of P. Vivax
Without Relapse by Day 120
|
35 participants
|
19 participants
|
|
Number of Subjects Without Relapse of P. Vivax
Unevaluable by Day 120
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 90 DaysTo evaluate the safety and tolerability of the tafenoquine dosing regimens as defined by the most common AE's overall, occurring in \>10% of subjects in either treatment group
Outcome measures
| Measure |
Cohort 1 Tafenoquine
n=46 Participants
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
n=24 Participants
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
|---|---|---|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Eosinophil count increased
|
5 AEs
|
3 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Blood methemoglobin present
|
46 AEs
|
22 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Headache
|
14 AEs
|
4 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Keratopathy
|
14 AEs
|
0 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Upper respiratory tract infection
|
13 AEs
|
5 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Dizziness
|
12 AEs
|
3 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Retinopathy
|
9 AEs
|
1 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Eosinophilia
|
8 AEs
|
7 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Abdominal pain
|
6 AEs
|
5 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Nausea
|
6 AEs
|
3 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Thrombocytopenia
|
6 AEs
|
0 AEs
|
|
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Pyrexia
|
5 AEs
|
3 AEs
|
SECONDARY outcome
Timeframe: up to day 7 after baseline smearPopulation: Intent to treat population
Serial blood smears to detect the presence of P. vivax parasites and gametocytes, conducted every 12 hours up to and including day 7, until blood smear became negative were utilized to determine the time to clearance. PCT and GCT were considered cleared if 2 consecutive blood smears were negative.
Outcome measures
| Measure |
Cohort 1 Tafenoquine
n=46 Participants
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
n=24 Participants
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
|---|---|---|
|
Parasite and Gametocyte Clearance Time (PCT and GCT)
Parasite Clearance Time
|
83.4 Hours
Standard Deviation 31.85
|
40.0 Hours
Standard Deviation 15.69
|
|
Parasite and Gametocyte Clearance Time (PCT and GCT)
Gametocyte Clearance Time
|
48.3 Hours
Standard Deviation 33.27
|
22.7 Hours
Standard Deviation 16.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through day 7Population: Intent to treat population
Measure of body temperature every 12 hours through day 7 was used to determine the time (to nearest 12 hours) from initiation of treatment until subjects temperature decreased to 37.2C and remained at or below that level for a minimum of 24 hours.
Outcome measures
| Measure |
Cohort 1 Tafenoquine
n=46 Participants
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
n=24 Participants
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
|---|---|---|
|
Fever Clearance Time (FCT)
|
41.5 Hours
Standard Deviation 30.61
|
24.7 Hours
Standard Deviation 17.69
|
Adverse Events
Cohort 1 Tafenoquine
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Cohort 1-Chloroquine
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Tafenoquine
n=46 participants at risk
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
n=24 participants at risk
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Acquired methaemoglobinaemia
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Gastric perforation
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Small intestine perforation
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Blood methaemoglobin present
|
6.5%
3/46 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
Other adverse events
| Measure |
Cohort 1 Tafenoquine
n=46 participants at risk
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
|
Cohort 1-Chloroquine
n=24 participants at risk
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Chloroquine + Primaquine: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
17.4%
8/46 • Number of events 8 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
29.2%
7/24 • Number of events 7 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.0%
6/46 • Number of events 6 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
2/46 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Blood and lymphatic system disorders
Acquired methaemoglobinaemia
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Ear and labyrinth disorders
Ear pain
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Eye disorders
Keratopathy
|
30.4%
14/46 • Number of events 14 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Eye disorders
Retinopathy
|
19.6%
9/46 • Number of events 9 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Eye disorders
Eye irritation
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Eye disorders
Retinal disorder
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Eye disorders
Eye pain
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
6/46 • Number of events 6 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
20.8%
5/24 • Number of events 5 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Nausea
|
13.0%
6/46 • Number of events 6 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
12.5%
3/24 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
3/46 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
3/46 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
2/46 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Toothache
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Aphthous atomatitis
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Food poisoning
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Gastric perforation
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Mouth ulcerations
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Peptic ulcer
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Pericoronitis
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
General disorders
Pyrexia
|
10.9%
5/46 • Number of events 5 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
12.5%
3/24 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
General disorders
Asthenia
|
8.7%
4/46 • Number of events 4 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
8.3%
2/24 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
General disorders
Fatigue
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
General disorders
Inflammation localised
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
General disorders
Influenza like illness
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Hepatobiliary disorders
Hepatomegaly
|
6.5%
3/46 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Hepatobiliary disorders
Hepatitis acute
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.3%
13/46 • Number of events 13 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
20.8%
5/24 • Number of events 5 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Infection subcutaneous abscess
|
4.3%
2/46 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Abscess limb
|
4.3%
2/46 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Herpes simplex
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Parasitic infection intestinal
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
8.3%
2/24 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
8.3%
2/24 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Bacterial infection
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Hordeolum
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Impetigo
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Lice infestation
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Nematodiasis
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Otitis media chronic
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Pharyngitis
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Tooth abscess
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Abscess
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Injury, poisoning and procedural complications
Wound
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Blood methaemoglobin present
|
47.8%
22/46 • Number of events 22 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Eosinophil count increased
|
10.9%
5/46 • Number of events 5 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
12.5%
3/24 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Hepatic enzyme abnormal
|
4.3%
2/46 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Band neutrophil count increased
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Blast cell count increased
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Blood bilirubin increased
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Blood creatinine increased
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
3/46 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
3/46 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Nervous system disorders
Headache
|
30.4%
14/46 • Number of events 14 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
16.7%
4/24 • Number of events 4 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Nervous system disorders
Dizziness
|
26.1%
12/46 • Number of events 12 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
12.5%
3/24 • Number of events 3 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Renal and urinary disorders
Dysuria
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Renal and urinary disorders
Haematuria
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Renal and urinary disorders
Haemoglobinuria
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Renal and urinary disorders
Leukocyturia
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
2/46 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.3%
2/46 • Number of events 2 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/46 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
4.2%
1/24 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
|
Vascular disorders
Hypotension
|
2.2%
1/46 • Number of events 1 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
0.00%
0/24 • 0 - 90 days
This study was terminated following completion of Cohort 1, and no subjects were enrolled into Cohort 2. Safety results are therefore presented for Cohort 1 only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place