Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers (NCT NCT02919696)
NCT ID: NCT02919696
Last Updated: 2020-09-25
Results Overview
Number of participants with one or more drug related adverse events. Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Baseline through End of Study (Up to 10 Months)
Results posted on
2020-09-25
Participant Flow
Participants who completed were those who had progressive disease or died due to any cause while on treatment. Pharmacokinetic (PK) samples were collected at lower doses during cycle 1.
Participant milestones
| Measure |
Abemaciclib 150 mg
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met.
One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met.
One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
|
Overall Study
Received at Least One Dose of Study Drug
|
12
|
13
|
|
Overall Study
PK 100 mg Abemaciclib Dose
|
5
|
0
|
|
Overall Study
PK 150 mg Abemaciclib Dose
|
0
|
2
|
|
Overall Study
Death On Treatment
|
1
|
0
|
|
Overall Study
Progressive Disease
|
7
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Abemaciclib 150 mg
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met.
One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met.
One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Sponsor Decision
|
1
|
1
|
|
Overall Study
Never Treated
|
0
|
1
|
Baseline Characteristics
A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers
Baseline characteristics by cohort
| Measure |
Abemaciclib 150 mg
n=12 Participants
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=13 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.58 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
52.00 years
STANDARD_DEVIATION 8.76 • n=7 Participants
|
53.72 years
STANDARD_DEVIATION 10.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through End of Study (Up to 10 Months)Population: All randomized participants who received at least one dose of study drug.
Number of participants with one or more drug related adverse events. Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Abemaciclib 150 mg
n=12 Participants
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=13 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|---|
|
Number of Participants With One or More Drug Related Adverse Events
|
12 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and its Metabolites following a single oral dose.
Outcome measures
| Measure |
Abemaciclib 150 mg
n=12 Participants
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=13 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites Single Dose
|
204 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 70
|
210 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 65
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day(D) 31; Predose, 1, 2, 4, 6, 8, 10, 24 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Maximum Concentration (Cmax) of Abemaciclib and its Metabolites following a twice daily dosing.
Outcome measures
| Measure |
Abemaciclib 150 mg
n=4 Participants
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=7 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=10 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites (Twice Daily Dosing)
|
205 ng/mL
Geometric Coefficient of Variation 64
|
267 ng/mL
Geometric Coefficient of Variation 71
|
320 ng/mL
Geometric Coefficient of Variation 91
|
SECONDARY outcome
Timeframe: Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Area Under Concentration Time Curve (AUC) from Time Zero to 12 hours (AUC \[0-12\]) of Abemaciclib and its Metabolites following a single oral dose.
Outcome measures
| Measure |
Abemaciclib 150 mg
n=12 Participants
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=13 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|---|
|
PK: Area Under Concentration Time Curve (AUC) From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites Single Dose
|
1700 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 75
|
1740 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 68
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day(D) 31; Predose, 1, 2, 4, 6, 8, 10, 24 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC from Time Zero to 12 hours (AUC \[0-12\]) of Abemaciclib and its Metabolites following twice daily dosing
Outcome measures
| Measure |
Abemaciclib 150 mg
n=4 Participants
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=7 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=10 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|---|
|
PK: AUC From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites (Twice Daily Dosing)
|
2190 ng*hr/mL
Geometric Coefficient of Variation 65
|
2770 ng*hr/mL
Geometric Coefficient of Variation 73
|
3270 ng*hr/mL
Geometric Coefficient of Variation 101
|
SECONDARY outcome
Timeframe: Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC from Time Zero to Infinity (AUC\[0-inf\]) of Abemaciclib and its Metabolites following a single oral dose.
Outcome measures
| Measure |
Abemaciclib 150 mg
n=12 Participants
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=13 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|---|
|
PK: AUC From Time Zero to Infinity (AUC[0-inf]) of Abemaciclib and Its Metabolites Single Dose
|
6790 ng*hr/mL
Geometric Coefficient of Variation 63
|
7580 ng*hr/mL
Geometric Coefficient of Variation 74
|
—
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease (Up to 13 Months )Population: All randomized participants who received at least one dose of study drug and had PR/CR data.
ORR was defined as the percentage of randomized participants with a best overall response of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the 20% increase must be at least one lesion must increase by an absolute value of ≥5 mm to be considered progression.
Outcome measures
| Measure |
Abemaciclib 150 mg
n=12 Participants
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=13 Participants
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|---|
|
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
|
8.3 percentage of participants
Interval 0.2 to 38.5
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
—
|
Adverse Events
Abemaciclib 150 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 6 deaths
Abemaciclib 200 mg
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Abemaciclib 150 mg
n=12 participants at risk
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=13 participants at risk
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
23.1%
3/13 • Number of events 3 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Abemaciclib 150 mg
n=12 participants at risk
Abemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
Abemaciclib 200 mg
n=13 participants at risk
Abemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
6/12 • Number of events 6 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
38.5%
5/13 • Number of events 7 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
2/12 • Number of events 7 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 6 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
3/12 • Number of events 3 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
9/12 • Number of events 24 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
84.6%
11/13 • Number of events 32 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival swelling
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 3 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
46.2%
6/13 • Number of events 10 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Periodontal disease
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • Number of events 8 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
30.8%
4/13 • Number of events 9 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
30.8%
4/13 • Number of events 6 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Localised oedema
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
58.3%
7/12 • Number of events 10 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
46.2%
6/13 • Number of events 8 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
23.1%
3/13 • Number of events 3 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
30.8%
4/13 • Number of events 4 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gingivitis
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
4/12 • Number of events 6 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
3/12 • Number of events 4 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Bilirubin conjugated increased
|
33.3%
4/12 • Number of events 4 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
33.3%
4/12 • Number of events 4 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin unconjugated increased
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
50.0%
6/12 • Number of events 7 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
61.5%
8/13 • Number of events 11 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood uric acid increased
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
75.0%
9/12 • Number of events 23 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
61.5%
8/13 • Number of events 20 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Occult blood
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
33.3%
4/12 • Number of events 5 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
38.5%
5/13 • Number of events 6 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Red blood cell count decreased
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
66.7%
8/12 • Number of events 17 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
46.2%
6/13 • Number of events 12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
83.3%
10/12 • Number of events 11 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
46.2%
6/13 • Number of events 7 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Glossopharyngeal nerve disorder
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • Number of events 3 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.7%
5/12 • Number of events 5 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
30.8%
4/13 • Number of events 5 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 4 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 3 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
2/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
16.7%
2/12 • Number of events 4 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Embolism
|
8.3%
1/12 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 2 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/12 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Up to 10 Months
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60