Trial Outcomes & Findings for Lorlatinib Renal Impairment Study (NCT NCT03542305)
NCT ID: NCT03542305
Last Updated: 2021-02-21
Results Overview
AUCinf was calculated by AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration; Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose
Results posted on
2021-02-21
Participant Flow
The mild renal impairment participants were recruited first. After lorlatinib was tolerated in at least 3 mild impairment participants, moderate impairment participants were enrolled. After dosing of 3 moderate impairment participants for at least 1 week, the remaining moderate impairment participants and the severe impairment participants were enrolled. The enrollment of normal renal function participants began after all renal impairment participants completed the PK collection.
Participant milestones
| Measure |
Normal Function
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
5
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lorlatinib Renal Impairment Study
Baseline characteristics by cohort
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg dose of lorlatinib tablets with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 3.66 • n=5 Participants
|
59.0 Years
STANDARD_DEVIATION 7.27 • n=7 Participants
|
63.1 Years
STANDARD_DEVIATION 4.88 • n=5 Participants
|
60.4 Years
STANDARD_DEVIATION 11.08 • n=4 Participants
|
59.7 Years
STANDARD_DEVIATION 6.81 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
white
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdosePopulation: The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.
AUCinf was calculated by AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration; Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib
|
8329 ng*hr/mL
Geometric Coefficient of Variation 33
|
8683 ng*hr/mL
Geometric Coefficient of Variation 29
|
9890 ng*hr/mL
Geometric Coefficient of Variation 27
|
11760 ng*hr/mL
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdosePopulation: The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.
Cmax was observed directly from data.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Lorlatinib
|
546.8 ng/mL
Geometric Coefficient of Variation 48
|
549.7 ng/mL
Geometric Coefficient of Variation 52
|
485.9 ng/mL
Geometric Coefficient of Variation 24
|
504.8 ng/mL
Geometric Coefficient of Variation 50
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after last dose of study treatment (approximately 29 days)Population: The analysis population included all participants who received at least 1 dose of study medication.
An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event did not need to have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Number of participants with both all-causality and treatment-related TEAEs are presented below.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
All-causality AEs
|
5 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
All-causality SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-related AEs
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Day -1, Day 2 and Day 6Population: The analysis population included all participants who received at least 1 dose of study medication.
The hematology, chemistry and urinalysis tests were included in the laboratory examination. Hematology evaluation included hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin concentration and erythrocyte mean corpuscular hemoglobin. Chemistry evaluation included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein, lipase and amylase. Urinalysis evaluation included decimal logarithm of reciprocal of hydrogen ion activity \[pH\], glucose, protein, blood, ketones, microscopy, ketones, nitrite, leukocyte esterase, urobilinogen, urine bilirubin and bacteria. The lab abnormalities were reported in accordance with the sponsor reporting standards.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormalities
|
4 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after last dose of study treatment (approximately 29 days)Population: The analysis population included all participants who received at least 1 dose of study medication.
Vital signs evaluations included supine diastolic blood pressure (DBP), and supine systolic blood pressure (SBP) were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest. Number of participants with vital signs data meeting the categorical summarization criteria is presented. The pre-specified criteria of vital signs data were categorized as follows: SBP (minimum) \<90 mmHg, maximum of decrease and increase from baseline for SBP \>=30 mmHg; DBP (minimum) \<50 mmHg, maximum of decrease and increase from baseline for DBP\>=20 mmHg.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria
Supine SBP < 90 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria
Supine SBP ≥ 30 mmHg increase
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria
Supine DBP < 50 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria
Supine DBP ≥ 20 mmHg increase
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria
Supine SBP ≥ 30 mmHg decrease
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria
Supine DBP ≥ 20 mmHg decrease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Day -1, 0 hours (pre-dose), 1 hour, 2 hours, 4 hours, 24 hours and 120 hours postdose.Population: The analysis population included all participants who received at least 1 dose of study medication.
ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), and QT interval corrected for heart rate using Fridericia's formula (QTcF interval). The pre-specified criteria of ESG data were categorized as below.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
PR interval ≥ 260msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
QRS interval >120 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
QT interval ≥ 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
QTcF interval ≥ 450 to <480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
QTcF interval ≥ 480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
PR interval change from baseline ≥ 60 to <80 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
QTcF interval change from baseline ≥ 30 to <60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
PR interval ≥ 200 to <240 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
PR interval ≥ 240 to <260 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
PR interval ≥ 200 to <220 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
PR interval change from baseline ≥ 40 to <60 msec
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
PR interval change from baseline ≥ 80 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
PR interval percent change from baseline > 25%
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
QRS interval percent change from baseline ≥ 50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
QTcF interval change from baseline ≥ 60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdosePopulation: The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.
AUClast was calculated by linear/Log trapezoidal method.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Lorlatinib
|
8015 ng*hr/mL
Geometric Coefficient of Variation 32
|
8307 ng*hr/mL
Geometric Coefficient of Variation 28
|
8867 ng*hr/mL
Geometric Coefficient of Variation 24
|
10310 ng*hr/mL
Geometric Coefficient of Variation 36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdosePopulation: The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.
Tmax was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Time for Cmax (Tmax) of Lorlatinib
|
1.50 hours
Interval 1.0 to 4.0
|
1.00 hours
Interval 1.0 to 1.5
|
1.25 hours
Interval 1.0 to 4.0
|
1.00 hours
Interval 1.0 to 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdosePopulation: The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.
t1/2 was calculated by ln(2)/kel.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Terminal Elimination Plasma Half-life (t½) of Lorlatinib
|
25.64 hours
Standard Deviation 4.7500
|
28.08 hours
Standard Deviation 3.5156
|
39.40 hours
Standard Deviation 7.1019
|
41.66 hours
Standard Deviation 7.6081
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdosePopulation: The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.
CL/F was calculated by Dose/AUCinf.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Apparent Clearance After Oral Dose (CL/F) of Lorlatinib
|
12.02 L/hr
Geometric Coefficient of Variation 33
|
11.51 L/hr
Geometric Coefficient of Variation 29
|
10.11 L/hr
Geometric Coefficient of Variation 27
|
8.51 L/hr
Geometric Coefficient of Variation 37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdosePopulation: The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.
Vz/F was calculated by Dose/(AUCinf\*kel). kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution Following Oral Dose (Vz/F) of Lorlatinib
|
436.9 L
Geometric Coefficient of Variation 24
|
462.9 L
Geometric Coefficient of Variation 27
|
566.2 L
Geometric Coefficient of Variation 21
|
503.8 L
Geometric Coefficient of Variation 36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdosePopulation: The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.
CLR was calculated by Ae/AUClast. Ae was cumulative amount of drug recovered unchanged in urine, which was calculated by sum of (urine concentration × sample volume) for each collection interval from 0 to time 120 hours postdose. Sample volume = (urine weight in g/1.020), where 1.020 g/mL is the approximate specific gravity of urine.
Outcome measures
| Measure |
Normal Function
n=8 Participants
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 Participants
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 Participants
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 Participants
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Renal Clearance (CLR) of Lorlatinib
|
0.1095 L/hr
Geometric Coefficient of Variation 42
|
0.1382 L/hr
Geometric Coefficient of Variation 50
|
0.08199 L/hr
Geometric Coefficient of Variation 55
|
0.06872 L/hr
Geometric Coefficient of Variation 45
|
Adverse Events
Normal Function
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Mild Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Moderate Impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Severe Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Function
n=8 participants at risk
Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Mild Impairment
n=8 participants at risk
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Moderate Impairment
n=8 participants at risk
Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
Severe Impairment
n=5 participants at risk
Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER