Trial Outcomes & Findings for Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010) (NCT NCT00944021)
NCT ID: NCT00944021
Last Updated: 2019-09-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
14 consecutive days of treatment
Results posted on
2019-09-20
Participant Flow
Participant milestones
| Measure |
PA-824 50 mg/qd
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
16
|
8
|
|
Overall Study
COMPLETED
|
14
|
15
|
15
|
16
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)
Baseline characteristics by cohort
| Measure |
PA-824 50 mg/qd
n=15 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=16 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
n=8 Participants
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
69 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 9.28 • n=7 Participants
|
26.9 years
STANDARD_DEVIATION 8.91 • n=5 Participants
|
25.3 years
STANDARD_DEVIATION 6.18 • n=4 Participants
|
33.3 years
STANDARD_DEVIATION 14.09 • n=21 Participants
|
28.6 years
STANDARD_DEVIATION 9.45 • n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
|
Region of Enrollment
South Africa
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
16 participants
n=4 Participants
|
8 participants
n=21 Participants
|
69 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 14 consecutive days of treatmentPopulation: All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=12 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=14 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=14 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
n=8 Participants
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).
|
0.063 log10CFU/ml/day
Standard Deviation 0.058
|
0.091 log10CFU/ml/day
Standard Deviation 0.073
|
0.078 log10CFU/ml/day
Standard Deviation 0.074
|
0.112 log10CFU/ml/day
Standard Deviation 0.070
|
0.177 log10CFU/ml/day
Standard Deviation 0.042
|
SECONDARY outcome
Timeframe: Two consecutive days of treatmentPopulation: All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=14 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=14 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
n=8 Participants
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).
|
0.093 log10CFU/ml/day
Standard Deviation 0.211
|
0.111 log10CFU/ml/day
Standard Deviation 0.332
|
-0.009 log10CFU/ml/day
Standard Deviation 0.290
|
0.160 log10CFU/ml/day
Standard Deviation 0.255
|
0.470 log10CFU/ml/day
Standard Deviation 0.316
|
SECONDARY outcome
Timeframe: Days 2-14 of 14 consecutive days of treatmentPopulation: All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=12 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=14 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=14 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
n=8 Participants
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).
|
0.059 log10CFU/ml/day
Standard Deviation 0.060
|
0.088 log10CFU/ml/day
Standard Deviation 0.085
|
0.096 log10CFU/ml/day
Standard Deviation 0.98
|
0.104 log10CFU/ml/day
Standard Deviation 0.083
|
0.128 log10CFU/ml/day
Standard Deviation 0.070
|
SECONDARY outcome
Timeframe: Fourteen consecutive days of treatmentPopulation: All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=13 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=14 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=16 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
n=8 Participants
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14).
|
2.621 hours/day
Standard Deviation 2.534
|
4.969 hours/day
Standard Deviation 3.644
|
4.633 hours/day
Standard Deviation 3.687
|
4.640 hours/day
Standard Deviation 3.447
|
13.364 hours/day
Standard Deviation 3.979
|
SECONDARY outcome
Timeframe: Two consecutive days of treatmentPopulation: All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=15 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=14 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=13 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
n=8 Participants
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2).
|
1.483 hours/day
Standard Deviation 8.153
|
-1.345 hours/day
Standard Deviation 8.586
|
4.867 hours/day
Standard Deviation 12.755
|
3.096 hours/day
Standard Deviation 8.202
|
37.016 hours/day
Standard Deviation 5.639
|
SECONDARY outcome
Timeframe: Days 2-14 of 14 consecutive days of treatmentPopulation: All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=13 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=13 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
n=8 Participants
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14).
|
2.958 hours/day
Standard Deviation 2.652
|
5.744 hours/day
Standard Deviation 3.973
|
4.594 hours/day
Standard Deviation 5.035
|
5.391 hours/day
Standard Deviation 3.608
|
9.422 hours/day
Standard Deviation 4.367
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatmentPopulation: All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=15 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=16 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1).
|
465.3 ng/mL
Standard Deviation 150.6
|
662.3 ng/mL
Standard Deviation 167.8
|
994.7 ng/mL
Standard Deviation 305.7
|
1183.0 ng/mL
Standard Deviation 382.5
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatmentPopulation: All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=15 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=16 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1).
|
11923.94 ng * hour/mL
Standard Deviation 4512.94
|
18408.59 ng * hour/mL
Standard Deviation 7665.35
|
28654.83 ng * hour/mL
Standard Deviation 10924.23
|
38485.04 ng * hour/mL
Standard Deviation 16606.96
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatmentPopulation: All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=15 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=16 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1).
|
16.142 hours
Standard Deviation 5.501
|
18.597 hours
Standard Deviation 9.459
|
19.005 hours
Standard Deviation 7.349
|
21.092 hours
Standard Deviation 6.490
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12,16, 24, and 30 hours post-dose on Day 14 of 14 consecutive days of treatmentPopulation: All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=15 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=16 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14).
|
777.3 ng/mL
Standard Deviation 250.7
|
1116.5 ng/mL
Standard Deviation 357.4
|
1543.9 ng/mL
Standard Deviation 511.4
|
2223.8 ng/mL
Standard Deviation 734.5
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24 and 30 hours post-dose on Day 14 of 14 consecutive days of treatmentPopulation: All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Outcome measures
| Measure |
PA-824 50 mg/qd
n=15 Participants
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 Participants
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 Participants
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=16 Participants
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14).
|
18.645 hour
Standard Deviation 5.394
|
19.274 hour
Standard Deviation 10.249
|
20.207 hour
Standard Deviation 5.288
|
23.811 hour
Standard Deviation 8.067
|
—
|
Adverse Events
PA-824 50 mg/qd
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
PA-824 100mg/qd
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PA-824 150mg/qd
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PA-824 200mg/qd
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Rifafour e-275mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PA-824 50 mg/qd
n=15 participants at risk
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 participants at risk
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 participants at risk
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=16 participants at risk
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
n=8 participants at risk
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.2%
1/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
Other adverse events
| Measure |
PA-824 50 mg/qd
n=15 participants at risk
PA-824 : 50mg oral tablet
|
PA-824 100mg/qd
n=15 participants at risk
PA-824 : 100mg oral tablet
|
PA-824 150mg/qd
n=15 participants at risk
PA-824 : 150 mg oral tablet
|
PA-824 200mg/qd
n=16 participants at risk
PA-824 : 200 mg oral tablet
|
Rifafour e-275mg
n=8 participants at risk
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
|
|---|---|---|---|---|---|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Eye disorders
Lenticular opacities
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
12.5%
1/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.2%
1/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
12.5%
1/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
12.5%
1/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
General disorders
Chills
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
General disorders
Fatigue
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Infections and infestations
Vaginal infection
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.2%
1/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Investigations
Heart rate increased
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.2%
1/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.2%
1/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.2%
1/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.2%
1/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
12.5%
1/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
12.5%
1/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.2%
1/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
18.8%
3/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
0.00%
0/16 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
12.5%
1/8 • 180 days
Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
|
Additional Information
Daniel E. Everitt, MD, Vice President and Senior Medical Officer
Global Alliance for TB Drug Development
Phone: 212 227 7540
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER