Trial Outcomes & Findings for A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension (NCT NCT01484431)
NCT ID: NCT01484431
Last Updated: 2019-10-09
Results Overview
Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil. The measure of dispersion reported is 90% Prediction Intervals and not Confidence Intervals.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Period 1: Pre Dose and 2, 4, 8, 12, and 24 Hours Post Dose on Days 1, 14 and 49; with single dose measures on Day 1 and steady-state measurements on Days 14 and 49
Results posted on
2019-10-09
Participant Flow
Per protocol, the summary was based on weight cohorts.
This study contains 2 periods: Pharmacokinetics(PK)/safety Period 1 and an open-label safety extension Period 2. Period 1 is approximately 10 weeks (that is, approximately 5 consecutive weeks for each dose \[low and high\]). Period 2 is at least 2 years after participating in Period 1.
Participant milestones
| Measure |
Heavy Weight: ≥40 kg
Period 1: 10 mg tadalafil tablet administered QD for 5 weeks then 20 mg or 40 mg tablet tadalafil administered QD for 5 weeks.
Period 2: Open Label Extension for 2 years.
15 mg, 20 mg or 40 mg tadalafil administered once daily (QD) in oral tablet.
|
Light Weight <25 kg
Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.
Period 2: Open Label Extension for 2 years.
7 mg, 8 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral suspension formulation.
|
Middle Weight: 25 kg to <40 kg
Period 1: 5 mg tadalafil tablet administered QD for 5 weeks then 10 mg, 15 mg or 20 mg tablet tadalafil administered QD for 5 weeks.
Period 2: Open Label Extension for 2 years.
7.5 mg, 10 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral tablet.
|
|---|---|---|---|
|
Period 1: Low Dose
STARTED
|
6
|
6
|
7
|
|
Period 1: Low Dose
Received 2 mg
|
0
|
1
|
0
|
|
Period 1: Low Dose
Received 4 mg
|
0
|
5
|
0
|
|
Period 1: Low Dose
Received 5 mg
|
0
|
0
|
7
|
|
Period 1: Low Dose
Received 10 mg
|
6
|
0
|
0
|
|
Period 1: Low Dose
COMPLETED
|
6
|
6
|
7
|
|
Period 1: Low Dose
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 1: High Dose
STARTED
|
6
|
6
|
7
|
|
Period 1: High Dose
Received 8 mg
|
0
|
1
|
0
|
|
Period 1: High Dose
Received 10 mg
|
0
|
1
|
1
|
|
Period 1: High Dose
Received 15 mg
|
0
|
1
|
1
|
|
Period 1: High Dose
Received 20 mg
|
1
|
3
|
5
|
|
Period 1: High Dose
Received 40 mg
|
5
|
0
|
0
|
|
Period 1: High Dose
COMPLETED
|
6
|
6
|
6
|
|
Period 1: High Dose
NOT COMPLETED
|
0
|
0
|
1
|
|
Period 2
STARTED
|
6
|
6
|
6
|
|
Period 2
Received 7 mg
|
0
|
1
|
0
|
|
Period 2
Received 7.5 mg
|
0
|
0
|
2
|
|
Period 2
Received 8 mg
|
0
|
1
|
0
|
|
Period 2
Received 10 mg
|
0
|
0
|
1
|
|
Period 2
Received 15 mg
|
1
|
1
|
2
|
|
Period 2
Received 20 mg
|
4
|
3
|
1
|
|
Period 2
Received 40 mg
|
1
|
0
|
0
|
|
Period 2
COMPLETED
|
4
|
5
|
5
|
|
Period 2
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Heavy Weight: ≥40 kg
Period 1: 10 mg tadalafil tablet administered QD for 5 weeks then 20 mg or 40 mg tablet tadalafil administered QD for 5 weeks.
Period 2: Open Label Extension for 2 years.
15 mg, 20 mg or 40 mg tadalafil administered once daily (QD) in oral tablet.
|
Light Weight <25 kg
Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.
Period 2: Open Label Extension for 2 years.
7 mg, 8 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral suspension formulation.
|
Middle Weight: 25 kg to <40 kg
Period 1: 5 mg tadalafil tablet administered QD for 5 weeks then 10 mg, 15 mg or 20 mg tablet tadalafil administered QD for 5 weeks.
Period 2: Open Label Extension for 2 years.
7.5 mg, 10 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral tablet.
|
|---|---|---|---|
|
Period 1: High Dose
Physician Decision
|
0
|
0
|
1
|
|
Period 2
Death
|
1
|
0
|
1
|
|
Period 2
Physician Decision
|
1
|
0
|
0
|
|
Period 2
Non-Compliance with Study Drug
|
0
|
1
|
0
|
Baseline Characteristics
A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Light Weight: <25 kg
n=6 Participants
Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.
|
Middle Weight: 25 kg to <40 kg
n=7 Participants
Period 1: 5 mg tadalafil tablet administered QD for 5 weeks then 10 mg, 15 mg or 20 mg tablet tadalafil administered QD for 5 weeks.
|
Heavy Weight: ≥40 kg
n=6 Participants
Period 1: 10 mg tadalafil tablet administered QD for 5 weeks then 20 mg or 40 mg tablet tadalafil administered QD for 5 weeks.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
5.00 years
n=5 Participants
|
10.91 years
n=7 Participants
|
14.45 years
n=5 Participants
|
10.16 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Period 1: Pre Dose and 2, 4, 8, 12, and 24 Hours Post Dose on Days 1, 14 and 49; with single dose measures on Day 1 and steady-state measurements on Days 14 and 49Population: All participants who received at least one dose of study drug and had evaluable PK data including all dose levels on Day 1, 14 and 49. Per protocol, the summary reflects potential exposure of the high dose within each weight cohort
Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil. The measure of dispersion reported is 90% Prediction Intervals and not Confidence Intervals.
Outcome measures
| Measure |
20 mg Light Weight: <25 kg
n=6 Participants
20 mg tadalafil administered QD in oral suspension formulation.
|
20 mg Middle Weight: 25 kg to <40 kg
n=7 Participants
20 mg tablet tadalafil administered QD.
|
40 mg Heavy Weight: ≥40 kg
n=6 Participants
40 mg tablet tadalafil administered QD.
|
|---|---|---|---|
|
Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil
Not Taking Bosentan
|
8170 nanograms* hour per milliliter(ng*hr/mL)
Interval 3850.0 to 16700.0
|
8390 nanograms* hour per milliliter(ng*hr/mL)
Interval 4130.0 to 18400.0
|
15200 nanograms* hour per milliliter(ng*hr/mL)
Interval 6980.0 to 31100.0
|
|
Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil
Taking Concomitant Bosentan
|
4550 nanograms* hour per milliliter(ng*hr/mL)
Interval 2170.0 to 9450.0
|
5000 nanograms* hour per milliliter(ng*hr/mL)
Interval 2440.0 to 10600.0
|
8990 nanograms* hour per milliliter(ng*hr/mL)
Interval 4270.0 to 19500.0
|
PRIMARY outcome
Timeframe: Period 1: Pre Dose and 2, 4, 8, 12, and 24 Hours Post Dose on Days 1, 14 and 49; with single dose measures on Day 1 and steady-state measurements on Days 14 and 49Population: All participants who received at least one dose of study drug and had evaluable PK data including all dose levels on Day 1, 14 and 49. Per protocol, the summary reflects potential exposure of the high dose within each weight cohort
Population Pharmacokinetics: Average Concentration (Cmean,ss) of for tadalafil at steady-state. The measure of dispersion reported is 90% Prediction Intervals and not Confidence Intervals.
Outcome measures
| Measure |
20 mg Light Weight: <25 kg
n=6 Participants
20 mg tadalafil administered QD in oral suspension formulation.
|
20 mg Middle Weight: 25 kg to <40 kg
n=7 Participants
20 mg tablet tadalafil administered QD.
|
40 mg Heavy Weight: ≥40 kg
n=6 Participants
40 mg tablet tadalafil administered QD.
|
|---|---|---|---|
|
Population Pharmacokinetics: Average Concentration (Cmean,ss) of for Tadalafil at Steady-State.
Not Taking Bosentan
|
340 nanograms per milliliter (ng/mL)
Interval 161.0 to 694.0
|
350 nanograms per milliliter (ng/mL)
Interval 172.0 to 767.0
|
633 nanograms per milliliter (ng/mL)
Interval 291.0 to 1300.0
|
|
Population Pharmacokinetics: Average Concentration (Cmean,ss) of for Tadalafil at Steady-State.
Taking Concomitant Bosentan
|
190 nanograms per milliliter (ng/mL)
Interval 90.4 to 394.0
|
209 nanograms per milliliter (ng/mL)
Interval 102.0 to 440.0
|
375 nanograms per milliliter (ng/mL)
Interval 178.0 to 815.0
|
SECONDARY outcome
Timeframe: Baseline Up to 27 MonthsPopulation: All participants who received at least one dose of study drug.
Clinical worsening was defined as any of the following: death, lung or heart transplantation, atrial septostomy or Potts' shunt, hospitalization for Pulmonary Arterial Hypertension (PAH) progression, new onset syncope, initiation of new PAH therapy (including increase in the dose of existing PAH specific concomitant therapy, such as endothelin receptor agonist or beraprost medication), or increase of 1 or more in World Health Organization(WHO) Functional Class (except for participants already in Class IV; only for participants unable to perform the 6 minute walk (6MW) test; worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk (6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance (for those participants who are ≥6 years of age).
Outcome measures
| Measure |
20 mg Light Weight: <25 kg
n=6 Participants
20 mg tadalafil administered QD in oral suspension formulation.
|
20 mg Middle Weight: 25 kg to <40 kg
n=7 Participants
20 mg tablet tadalafil administered QD.
|
40 mg Heavy Weight: ≥40 kg
n=6 Participants
40 mg tablet tadalafil administered QD.
|
|---|---|---|---|
|
Percentage of Participants With Clinical Worsening
|
50.00 percentage of participants
|
28.57 percentage of participants
|
33.33 percentage of participants
|
SECONDARY outcome
Timeframe: Day 35 (high dose)Population: Participants who received at least one oral suspension dose of study drug in the Light-weight cohort (≥2 years of age). Per protocol, palatability of the tadalafil suspension was evaluated in the Light-weight cohort only.
The Taste Assessment Questionnaire (TAQ) questions were: TAQRES1: Please rate the bitterness level. TAQRES2: Please rate the sweetness level. TAQRES3: Please rate the aftertaste. TAQRES4: Please rate the overall acceptability of the taste for daily use.
Outcome measures
| Measure |
20 mg Light Weight: <25 kg
n=3 Participants
20 mg tadalafil administered QD in oral suspension formulation.
|
20 mg Middle Weight: 25 kg to <40 kg
20 mg tablet tadalafil administered QD.
|
40 mg Heavy Weight: ≥40 kg
40 mg tablet tadalafil administered QD.
|
|---|---|---|---|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES1: Extremely bitter
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES1: Very bitter
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES1: Moderately bitter
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES1: Slightly bitter
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES1: Not bitter
|
3 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES2: Extremely sweet
|
1 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES2: Very sweet
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES2: Moderately sweet
|
1 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES2: Slightly sweet
|
1 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES2: Not sweet
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES3: Extreme aftertaste
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES3: Strong aftertaste
|
1 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES3: Moderate aftertaste
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES3:Slight aftertaste
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES3:No aftertaste
|
2 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES4: Not acceptable
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES4: Slightly acceptable
|
0 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES4: Acceptable
|
2 Participants
|
—
|
—
|
|
Number of Participants With Palatability of the Tadalafil Suspension
TAQRES4: Very acceptable
|
1 Participants
|
—
|
—
|
Adverse Events
Light Weight: <25 kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Middle Weight: 25 kg to <40 kg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Heavy Weight: ≥40 kg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Light Weight: <25 kg
n=6 participants at risk
Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.
Period 2: Open Label Extension for 2 years.
7 mg, 8 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral suspension formulation.
|
Middle Weight: 25 kg to <40 kg
n=7 participants at risk
Period 1: 5 mg tadalafil tablet administered QD for 5 weeks then 10 mg, 15 mg or 20 mg tablet tadalafil administered QD for 5 weeks.
Period 2: Open Label Extension for 2 years.
7.5 mg, 10 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral tablet.
.
|
Heavy Weight: ≥40 kg
n=6 participants at risk
Period 1: 10 mg tadalafil tablet administered QD for 5 weeks then 20 mg or 40 mg tablet tadalafil administered QD for 5 weeks.
Period 2: Open Label Extension for 2 years.
15 mg, 20 mg or 40 mg tadalafil administered once daily (QD) in oral tablet.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia viral
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/4 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 3 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Light Weight: <25 kg
n=6 participants at risk
Period 1: 2 milligram (mg) or 4 mg tadalafil administered once daily (QD) in oral suspension formulation for 5 weeks then 8 mg,10 mg,15 mg or 20 mg tadalafil was administered QD in oral suspension formulation for 5 weeks.
Period 2: Open Label Extension for 2 years.
7 mg, 8 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral suspension formulation.
|
Middle Weight: 25 kg to <40 kg
n=7 participants at risk
Period 1: 5 mg tadalafil tablet administered QD for 5 weeks then 10 mg, 15 mg or 20 mg tablet tadalafil administered QD for 5 weeks.
Period 2: Open Label Extension for 2 years.
7.5 mg, 10 mg, 15 mg or 20 mg tadalafil administered once daily (QD) in oral tablet.
.
|
Heavy Weight: ≥40 kg
n=6 participants at risk
Period 1: 10 mg tadalafil tablet administered QD for 5 weeks then 20 mg or 40 mg tablet tadalafil administered QD for 5 weeks.
Period 2: Open Label Extension for 2 years.
15 mg, 20 mg or 40 mg tadalafil administered once daily (QD) in oral tablet.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Hypermetropia
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 3 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anal fissure
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Faeces soft
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
28.6%
2/7 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Face oedema
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Puncture site pain
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 4 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Thirst
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
33.3%
2/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Ear infection
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 3 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
50.0%
3/6 • Number of events 4 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Laryngitis
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
2/6 • Number of events 5 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis media acute
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 5 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Toxoplasmosis
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Cytogenetic analysis abnormal
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Electrocardiogram qt prolonged
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Exercise test abnormal
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
28.6%
2/7 • Number of events 3 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Disturbance in attention
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
28.6%
2/7 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/4 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/4 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/4 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 3 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
42.9%
3/7 • Number of events 3 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
2/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
33.3%
2/6 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 4 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
28.6%
2/7 • Number of events 2 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Vasodilatation
|
16.7%
1/6 • Number of events 1 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up To 27 Months
All participants who received at least one dose of study drug. Participants were first administered a low dose to explore PK of tadalafil and determine a high dose within the weight cohort. Per protocol, the summary was based on weight cohorts. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60