Trial Outcomes & Findings for A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis (NCT NCT00550043)
NCT ID: NCT00550043
Last Updated: 2015-03-23
Results Overview
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Day 28
Results posted on
2015-03-23
Participant Flow
Participant milestones
| Measure |
Placebo
|
Cohort 1: Treatment Group A
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
9
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
8
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo
|
Cohort 1: Treatment Group A
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Subject Withdrew Consent
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Other Reasons- Unspecified
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 8.44 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 11.29 • n=4 Participants
|
54.5 years
STANDARD_DEVIATION 14.14 • n=21 Participants
|
54.9 years
STANDARD_DEVIATION 11.23 • n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: modified intent-to-treat (mITT) Population: subjects enrolled, took 1 dose of study drug, had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects discontinuing before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Outcome measures
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
No Response
|
66.7 Percentage of participants
|
16.7 Percentage of participants
|
66.7 Percentage of participants
|
40.0 Percentage of participants
|
40.0 Percentage of participants
|
|
The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
Response
|
33.3 Percentage of participants
|
83.3 Percentage of participants
|
33.3 Percentage of participants
|
60.0 Percentage of participants
|
60.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Outcome measures
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
The Percentage of Subjects Achieving ACR 50 Improvement
Response
|
11.1 Percentage of participants
|
50.0 Percentage of participants
|
11.1 Percentage of participants
|
40.0 Percentage of participants
|
50.0 Percentage of participants
|
|
The Percentage of Subjects Achieving ACR 50 Improvement
No Response
|
88.9 Percentage of participants
|
50.0 Percentage of participants
|
88.9 Percentage of participants
|
60.0 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
The ACR 70 is defined as ≥ 70% improvement in tender joint count plus ≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Outcome measures
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
The Percentage of Subjects Achieving ACR 70 Improvement
No response
|
100.0 Percentage of participants
|
75.0 Percentage of participants
|
100.0 Percentage of participants
|
70.0 Percentage of participants
|
70.0 Percentage of participants
|
|
The Percentage of Subjects Achieving ACR 70 Improvement
Response
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
30.0 Percentage of participants
|
30.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.
Outcome measures
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score
|
1.32 Units on a scale
Standard Deviation 0.845
|
2.72 Units on a scale
Standard Deviation 1.250
|
1.09 Units on a scale
Standard Deviation 1.107
|
2.53 Units on a scale
Standard Deviation 1.454
|
2.88 Units on a scale
Standard Deviation 1.225
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\>5.1=high disease activity; \<3.2=low disease activity; \<2.6=remission).
Outcome measures
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score
|
1.14 Units on a scale
Standard Deviation 0.907
|
2.27 Units on a scale
Standard Deviation 1.177
|
0.92 Units on a scale
Standard Deviation 0.985
|
2.33 Units on a scale
Standard Deviation 1.840
|
2.64 Units on a scale
Standard Deviation 1.275
|
SECONDARY outcome
Timeframe: Day 28Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
Subjects who achieved low disease activity based on the DAS 28 ESR (score \<3.2). Subjects who achieved low disease activity were classified as responders in this analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Achieved DAS 28 ESR Low Disease
Non-responders
|
100.0 Percentage of participants
|
50.0 Percentage of participants
|
100.0 Percentage of participants
|
90.0 Percentage of participants
|
60.0 Percentage of participants
|
|
Percentage of Subjects Who Achieved DAS 28 ESR Low Disease
Responders
|
0.0 Percentage of participants
|
50.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
40.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
Subjects who achieved low disease activity based on the DAS 28 CRP (score \<3.2). Subjects who achieved low disease activity were classified as responders in this analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Achieved DAS 28 CRP Low Disease
Non-responders
|
100.0 Percentage of participants
|
50.0 Percentage of participants
|
100.0 Percentage of participants
|
70.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Subjects Who Achieved DAS 28 CRP Low Disease
Responders
|
0.0 Percentage of participants
|
50.0 Percentage of participants
|
0.0 Percentage of participants
|
30.0 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
Subjects who achieved inactive disease based on the DAS 28 ESR (score \<2.6). Subjects who achieved low disease activity were classified as responders in this analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease
Non-responders
|
100.0 Percentage of participants
|
75.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
90.0 Percentage of participants
|
|
Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease
Responders
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
Subjects who achieved inactive disease based on DAS 28 CRP (score \<2.6). Subjects who achieved low disease activity were classified as responders in this analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
|
Cohort 1: Treatment Group A
n=12 Participants
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 Participants
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 Participants
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 Participants
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease
Non-responders
|
100.0 Percentage of participants
|
75.0 Percentage of participants
|
100.0 Percentage of participants
|
90.0 Percentage of participants
|
70.0 Percentage of participants
|
|
Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease
Responders
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
30.0 Percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1: Treatment Group A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: Treatment Group B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: Treatment Group C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: Treatment Group D
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=9 participants at risk
|
Cohort 1: Treatment Group A
n=12 participants at risk
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 participants at risk
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 participants at risk
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 participants at risk
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Cardiac disorders
Congestive cardiac failure
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
Other adverse events
| Measure |
Placebo
n=9 participants at risk
|
Cohort 1: Treatment Group A
n=12 participants at risk
INCB018424 15 mg BID
|
Cohort 2: Treatment Group B
n=9 participants at risk
INCB018424 5 mg BID
|
Cohort 2: Treatment Group C
n=10 participants at risk
INCB018424 25 mg BID
|
Cohort 2: Treatment Group D
n=10 participants at risk
INCB018424 50 mg QD
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
8.3%
1/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
20.0%
2/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Eye disorders
Ocular hyperaemia
|
11.1%
1/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
8.3%
1/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
8.3%
1/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
General disorders
Chest pain
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
8.3%
1/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Infections and infestations
Oral herpes
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
8.3%
1/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
8.3%
1/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
8.3%
1/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Haematocrit decreased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
20.0%
2/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Haemoglobin decreased
|
11.1%
1/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
20.0%
2/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Mean cell volume increased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Occult blood positive
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Red cell distribution width increased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
11.1%
1/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
22.2%
2/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
8.3%
1/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
11.1%
1/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
|
Surgical and medical procedures
Mass excision
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/12 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/9 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
0.00%
0/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
10.0%
1/10 • Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.
Treatment-Emergent Adverse Events are those that either newly occurred after the first study drug dosing, or worsened from baseline
|
Additional Information
Study Director
Incyte Corporation
Phone: 1-855-463-3463
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER