Trial Outcomes & Findings for A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body (NCT NCT02688088)
NCT ID: NCT02688088
Last Updated: 2022-10-18
Results Overview
Maximum concentration of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours (hr) Postdose
Results posted on
2022-10-18
Participant Flow
Abemaciclib dose adjustments were allowed due to drug-related toxicity. Before the start of each cycle, drug-related toxicities must have resolved to either baseline or at least Grade 2. Participants not recovered from toxicities within 14 days were discontinued from the study. For Period 2, if abemaciclib dose adjustments occurred, dosing with the drug cocktail was permitted to be delayed to allow for adequate exposure.
Participant milestones
| Measure |
Drug Cocktail - Period 1
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
|
200 mg Abemaciclib + Drug Cocktail - Period 2
200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
|
200 mg Abemaciclib - Period 3
200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3.
.
|
200 mg Abemaciclib Period - 4
200 mg Abemaciclib administered orally Q12H on Days 1 to 28 in Period 4.
|
Abemaciclib Safety Extension Period
200 mg Abemaciclib administered orally Q12H on Days 1 to 28 onwards in extension period.
|
|---|---|---|---|---|---|
|
Single Dose Drug Cocktail - Period 1
STARTED
|
44
|
0
|
0
|
0
|
0
|
|
Single Dose Drug Cocktail - Period 1
Received One Dose of Drug Cocktail
|
44
|
0
|
0
|
0
|
0
|
|
Single Dose Drug Cocktail - Period 1
COMPLETED
|
44
|
0
|
0
|
0
|
0
|
|
Single Dose Drug Cocktail - Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Abemaciclib + Drug Cocktail - Period 2
STARTED
|
0
|
44
|
0
|
0
|
0
|
|
Abemaciclib + Drug Cocktail - Period 2
Received at Least One Dose of Study Drug
|
0
|
42
|
0
|
0
|
0
|
|
Abemaciclib + Drug Cocktail - Period 2
COMPLETED
|
0
|
37
|
0
|
0
|
0
|
|
Abemaciclib + Drug Cocktail - Period 2
NOT COMPLETED
|
0
|
7
|
0
|
0
|
0
|
|
Abemaciclib Days 13 to 28 - Period 3
STARTED
|
0
|
0
|
37
|
0
|
0
|
|
Abemaciclib Days 13 to 28 - Period 3
Received at Least One Dose of Study Drug
|
0
|
0
|
36
|
0
|
0
|
|
Abemaciclib Days 13 to 28 - Period 3
COMPLETED
|
0
|
0
|
29
|
0
|
0
|
|
Abemaciclib Days 13 to 28 - Period 3
NOT COMPLETED
|
0
|
0
|
8
|
0
|
0
|
|
Abemaciclib Days 1 to 28 - Period 4
STARTED
|
0
|
0
|
0
|
29
|
0
|
|
Abemaciclib Days 1 to 28 - Period 4
COMPLETED
|
0
|
0
|
0
|
21
|
0
|
|
Abemaciclib Days 1 to 28 - Period 4
NOT COMPLETED
|
0
|
0
|
0
|
8
|
0
|
|
Abemaciclib Safety Extension Period
STARTED
|
0
|
0
|
0
|
0
|
18
|
|
Abemaciclib Safety Extension Period
Received at Least One Dose of Study Drug
|
0
|
0
|
0
|
0
|
18
|
|
Abemaciclib Safety Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Abemaciclib Safety Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
18
|
Reasons for withdrawal
| Measure |
Drug Cocktail - Period 1
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
|
200 mg Abemaciclib + Drug Cocktail - Period 2
200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
|
200 mg Abemaciclib - Period 3
200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3.
.
|
200 mg Abemaciclib Period - 4
200 mg Abemaciclib administered orally Q12H on Days 1 to 28 in Period 4.
|
Abemaciclib Safety Extension Period
200 mg Abemaciclib administered orally Q12H on Days 1 to 28 onwards in extension period.
|
|---|---|---|---|---|---|
|
Abemaciclib + Drug Cocktail - Period 2
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Abemaciclib + Drug Cocktail - Period 2
Death
|
0
|
1
|
0
|
0
|
0
|
|
Abemaciclib + Drug Cocktail - Period 2
Withdrawal by Subject
|
0
|
3
|
0
|
0
|
0
|
|
Abemaciclib + Drug Cocktail - Period 2
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
|
Abemaciclib Days 13 to 28 - Period 3
Physician Decision
|
0
|
0
|
7
|
0
|
0
|
|
Abemaciclib Days 13 to 28 - Period 3
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Abemaciclib Days 1 to 28 - Period 4
Physician Decision
|
0
|
0
|
0
|
7
|
0
|
|
Abemaciclib Days 1 to 28 - Period 4
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Abemaciclib Safety Extension Period
Met Discontinuation Criteria
|
0
|
0
|
0
|
0
|
18
|
Baseline Characteristics
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
Baseline characteristics by cohort
| Measure |
Overall
n=44 Participants
A single dose of drug cocktail was administered on Day 1 of Period 1. Abemaciclib 200 mg was administered Q12H starting on Day 1 of Period 2 with coadministration of drug cocktail on Day 8. Participants continued to receive 200 mg abemaciclib (or modified dose as required) Q12H up to 16 days in Period 3 and up to 28 days in Period 4. Participants could participate in a safety extension phase in which they received 200 mg abemaciclib (or modified dose as required) Q12H until discontinuation criteria are met.
|
|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours (hr) PostdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Maximum concentration of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Outcome measures
| Measure |
100 mg Caffeine
n=39 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
n=32 Participants
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine
|
2890 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
2950 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Days 1 and 8: Predose, 0.5 1, 2, 3, 4, 6, 8, 12, 48, 72, 96 hr PostdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Maximum concentration of S-warfarin after single dose of drug cocktail on Day 1 in Period 1and in combination with Abemaciclib on Day 8 in Period 2.
Outcome measures
| Measure |
100 mg Caffeine
n=44 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
n=30 Participants
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) S-Warfarin
|
561 ng/mL
Geometric Coefficient of Variation 35
|
526 ng/mL
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: Days 1 and 8: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72 hr postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Maximum concentration of dextromethorphan after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Outcome measures
| Measure |
100 mg Caffeine
n=43 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
n=36 Participants
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Dextromethorphan
|
3.18 ng/mL
Geometric Coefficient of Variation 182
|
3.30 ng/mL
Geometric Coefficient of Variation 164
|
PRIMARY outcome
Timeframe: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr PostdosePopulation: All subjects who received at least one dose of study drug and had evaluable PK data.
Maximum concentration of midazolam after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Outcome measures
| Measure |
100 mg Caffeine
n=44 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
n=39 Participants
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Midazolam
|
2.12 ng/mL
Geometric Coefficient of Variation 54
|
1.75 ng/mL
Geometric Coefficient of Variation 48
|
PRIMARY outcome
Timeframe: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hr PostdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC zero to infinity of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Outcome measures
| Measure |
100 mg Caffeine
n=37 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
n=30 Participants
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Caffeine
|
32500 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 72
|
47100 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 89
|
PRIMARY outcome
Timeframe: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hr PostdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
AUC (zero to infinity) of S-warfarin after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Outcome measures
| Measure |
100 mg Caffeine
n=44 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
n=30 Participants
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of S-Warfarin
|
21400 ng*h/mL
Geometric Coefficient of Variation 43
|
20600 ng*h/mL
Geometric Coefficient of Variation 40
|
PRIMARY outcome
Timeframe: Days 1 and 8: 1, 2, 4, 6, 8, 10, 24, 48, 72 hr PostdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC (zero to infinity) of dextromethorphan after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Outcome measures
| Measure |
100 mg Caffeine
n=42 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
n=35 Participants
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Dextromethorphan
|
32.6 ng*h/mL
Geometric Coefficient of Variation 316
|
32.1 ng*h/mL
Geometric Coefficient of Variation 238
|
PRIMARY outcome
Timeframe: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr PostdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC (zero to infinity) of midazolam after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Outcome measures
| Measure |
100 mg Caffeine
n=44 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
n=37 Participants
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Midazolam
|
7.34 ng*h/mL
Geometric Coefficient of Variation 74
|
6.03 ng*h/mL
Geometric Coefficient of Variation 63
|
SECONDARY outcome
Timeframe: Day 8: Baseline, 24 h postdosePopulation: All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Mean change from predose in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose drug cocktail in Period 1.
Outcome measures
| Measure |
100 mg Caffeine
n=44 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 1
Systolic BP
|
-2.5 millimeter of mercury (mmHg)
Standard Deviation 13.9
|
—
|
|
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 1
Diastolic BP
|
-0.7 millimeter of mercury (mmHg)
Standard Deviation 10.1
|
—
|
SECONDARY outcome
Timeframe: Day 8: Baseline, 24 h postdosePopulation: All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 1.
Outcome measures
| Measure |
100 mg Caffeine
n=44 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 1
|
-1.3 Beats per minute (bpm)
Standard Deviation 11.1
|
—
|
SECONDARY outcome
Timeframe: Day 1: Baseline, 24 h postdosePopulation: All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Mean change from baseline in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose of abemaciclib in Period 2, Day 1.
Outcome measures
| Measure |
100 mg Caffeine
n=41 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Systolic BP
|
-7.8 mmHg
Standard Deviation 15.2
|
—
|
|
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Diastolic BP
|
-1.8 mmHg
Standard Deviation 10.4
|
—
|
SECONDARY outcome
Timeframe: Day 1: Baseline, 24 h postdosePopulation: All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 2, Day 1.
Outcome measures
| Measure |
100 mg Caffeine
n=41 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
|
-0.2 bpm
Standard Deviation 12.5
|
—
|
SECONDARY outcome
Timeframe: Day 8: Baseline, 24 h postdosePopulation: All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Mean change from baseline in systolic and diastolic blood pressure (BP) at 24 h postdose following 200 mg abemaciclib and drug cocktail.
Outcome measures
| Measure |
100 mg Caffeine
n=39 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Systolic BP
|
-11.6 mmHg
Standard Deviation 16.8
|
—
|
|
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Diastolic BP
|
-6.1 mmHg
Standard Deviation 10.5
|
—
|
SECONDARY outcome
Timeframe: Day 8: Baseline, 24 h postdosePopulation: All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Mean change from baseline in pulse rate at 24 h postdose following 200 mg abemaciclib and drug cocktail.
Outcome measures
| Measure |
100 mg Caffeine
n=39 Participants
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
|
Abemaciclib + 100 mg Caffeine
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
|
|---|---|---|
|
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
|
4.1 bpm
Standard Deviation 14.9
|
—
|
Adverse Events
Drug Cocktail - Period 1
Serious events: 1 serious events
Other events: 22 other events
Deaths: 1 deaths
200 mg Abemaciclib - Period 2
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
200 mg Abemaciclib + Drug Cocktail - Period 2
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
200 mg Abemaciclib - Periods 3 and 4
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Abemaciclib Safety Extension Period
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug Cocktail - Period 1
n=44 participants at risk
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
|
200 mg Abemaciclib - Period 2
n=42 participants at risk
200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 to 12 in Period 2.
|
200 mg Abemaciclib + Drug Cocktail - Period 2
n=35 participants at risk
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2. Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
|
200 mg Abemaciclib - Periods 3 and 4
n=28 participants at risk
200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3, and Days 1 to 28 in Period 4.
|
Abemaciclib Safety Extension Period
n=18 participants at risk
200 mg Abemaciclib administered orally Q12H until discontinuation criteria are met.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.9%
1/35 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.9%
1/35 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
General disorders
Medical device complication
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Sepsis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Investigations
Platelet count decreased
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.9%
1/35 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
Other adverse events
| Measure |
Drug Cocktail - Period 1
n=44 participants at risk
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
|
200 mg Abemaciclib - Period 2
n=42 participants at risk
200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 to 12 in Period 2.
|
200 mg Abemaciclib + Drug Cocktail - Period 2
n=35 participants at risk
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2. Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
|
200 mg Abemaciclib - Periods 3 and 4
n=28 participants at risk
200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3, and Days 1 to 28 in Period 4.
|
Abemaciclib Safety Extension Period
n=18 participants at risk
200 mg Abemaciclib administered orally Q12H until discontinuation criteria are met.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.7%
2/35 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
21.4%
6/28 • Number of events 6 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 6 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 4 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Eye disorders
Vision blurred
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
4.8%
2/42 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
2/44 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
14.3%
6/42 • Number of events 6 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.7%
2/35 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
16.7%
3/18 • Number of events 5 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
4.8%
2/42 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.7%
2/35 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
2/44 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
3/42 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.4%
4/35 • Number of events 4 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
16.7%
3/18 • Number of events 4 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
42.9%
18/42 • Number of events 18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
31.4%
11/35 • Number of events 11 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
42.9%
12/28 • Number of events 12 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 5 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
4.8%
2/42 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.7%
2/35 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.9%
1/35 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
5/44 • Number of events 5 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
19.0%
8/42 • Number of events 9 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
17.1%
6/35 • Number of events 6 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
25.0%
7/28 • Number of events 8 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
22.2%
4/18 • Number of events 5 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
2/44 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
19.0%
8/42 • Number of events 9 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
14.3%
5/35 • Number of events 7 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
25.0%
7/28 • Number of events 9 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
22.2%
4/18 • Number of events 6 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
General disorders
Fatigue
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
14.3%
6/42 • Number of events 6 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
17.1%
6/35 • Number of events 6 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
17.9%
5/28 • Number of events 5 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
16.7%
3/18 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
General disorders
Gait disturbance
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
General disorders
Local swelling
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
General disorders
Oedema
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
4.8%
2/42 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
General disorders
Pain
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
General disorders
Pyrexia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Hepatobiliary disorders
Portal vein stenosis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
2/44 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
16.7%
3/18 • Number of events 4 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Investigations
Blood bilirubin increased
|
4.5%
2/44 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
9.5%
4/42 • Number of events 4 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
10.7%
3/28 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
16.7%
3/18 • Number of events 4 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Investigations
International normalised ratio increased
|
15.9%
7/44 • Number of events 7 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
4.8%
2/42 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
8.6%
3/35 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Investigations
Lipase increased
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
14.3%
4/28 • Number of events 5 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Investigations
Platelet count decreased
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Investigations
Weight decreased
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
14.3%
4/28 • Number of events 4 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
3/42 • Number of events 4 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.4%
4/35 • Number of events 4 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
21.4%
6/28 • Number of events 7 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
27.8%
5/18 • Number of events 5 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
3/42 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.4%
4/35 • Number of events 5 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.9%
5/42 • Number of events 6 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
17.9%
5/28 • Number of events 6 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
16.7%
3/18 • Number of events 7 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.9%
1/35 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
2/44 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
4.8%
2/42 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.9%
1/35 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
4.8%
2/42 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Nervous system disorders
Dysgeusia
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Nervous system disorders
Headache
|
4.5%
2/44 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Nervous system disorders
Tremor
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.7%
2/35 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.9%
1/35 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Psychiatric disorders
Depression
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Psychiatric disorders
Insomnia
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
11.1%
2/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.7%
2/35 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
10.7%
3/28 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
2.4%
1/42 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
7.1%
2/28 • Number of events 2 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Vascular disorders
Hypotension
|
2.3%
1/44 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
8.6%
3/35 • Number of events 3 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
3.6%
1/28 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/18 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/44 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/42 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/35 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
0.00%
0/28 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
|
5.6%
1/18 • Number of events 1 • Baseline up to 46 days
All participants who received at least one dose of study drug and have at least one postdose safety assessment. As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60