Trial Outcomes & Findings for Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy (NCT NCT00986440)

Last Updated: 2020-11-05

Results Overview

Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

18 weeks postdose

Results posted on

2020-11-05

Participant Flow

A total of 84 participants who met all inclusion criteria and no exclusion criteria were enrolled at 46 clinic sites in Europe. Of the 84 participants enrolled, 83 received treatment.

Participants who were randomized to treatment (CS-7017 0.5 mg or placebo) started treatment within 8 weeks of completing first-line therapy.

Participant milestones

Participant milestones
Measure	CS-7017 0.5 mg Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo Participants who were randomized to receive matching placebo.
Overall Study STARTED	41	43
Overall Study Randomized, But Not Dosed	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	41	43

Reasons for withdrawal

Reasons for withdrawal
Measure	CS-7017 0.5 mg Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo Participants who were randomized to receive matching placebo.
Overall Study Progressive disease	27	37
Overall Study Serious adverse event or adverse event	9	2
Overall Study Withdrawal by Subject	1	2
Overall Study Screen failure (not dosed)	4	2

Baseline Characteristics

Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CS-7017 0.5 mg n=41 Participants Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo n=43 Participants Participants who were randomized to receive matching placebo.	Total n=84 Participants Total of all reporting groups
Age, Continuous	64.0 years STANDARD_DEVIATION 7.69 • n=93 Participants	60.9 years STANDARD_DEVIATION 9.73 • n=4 Participants	62.4 years STANDARD_DEVIATION 8.88 • n=27 Participants
Age, Customized <65 years	24 Participants n=93 Participants	26 Participants n=4 Participants	50 Participants n=27 Participants
Age, Customized ≥65 years	17 Participants n=93 Participants	17 Participants n=4 Participants	34 Participants n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	19 Participants n=4 Participants	38 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	24 Participants n=4 Participants	46 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	40 Participants n=93 Participants	41 Participants n=4 Participants	81 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: 18 weeks postdose

Population: PFS was assessed in the Full Analysis Set.

Outcome measures

Outcome measures
Measure	CS-7017 0.5 mg n=39 Participants Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo n=42 Participants Participants who were randomized to receive matching placebo.
Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy	39.86 percentage of participants Interval 23.5 to 55.7	25.00 percentage of participants Interval 13.0 to 39.0

SECONDARY outcome

Timeframe: At 12, 24, and 30 weeks postdose

Population: PFS was assessed in the Full Analysis Set.

Outcome measures

Outcome measures
Measure	CS-7017 0.5 mg n=39 Participants Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo n=42 Participants Participants who were randomized to receive matching placebo.
Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Progression-free survival at 12 weeks	62.0 percentage of participants Interval 44.6 to 75.5	47.5 percentage of participants Interval 31.6 to 61.8
Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Progression-free survival at 24 weeks	29.9 percentage of participants Interval 15.4 to 45.9	15.0 percentage of participants Interval 6.1 to 27.6
Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Progression-free survival at 30 weeks	29.9 percentage of participants Interval 15.4 to 45.9	12.5 percentage of participants Interval 4.6 to 24.6

SECONDARY outcome

Timeframe: At 3, 6, 9, and 12 months postdose

Population: OS was assessed in the Full Analysis Set.

Overall survival (OS) was defined as the time from the date of enrollment to the date of death and assessed by Kaplan Meier analysis.

Outcome measures

Outcome measures
Measure	CS-7017 0.5 mg n=39 Participants Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo n=42 Participants Participants who were randomized to receive matching placebo.
Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Overall survival rate at 3 months	100.0 percentage of participants Interval 100.0 to 100.0	92.9 percentage of participants Interval 79.5 to 97.6
Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Overall survival rate at 6 months	87.2 percentage of participants Interval 71.9 to 94.5	85.5 percentage of participants Interval 70.4 to 93.2
Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Overall survival rate at 9 months	74.4 percentage of participants Interval 57.6 to 85.3	75.2 percentage of participants Interval 58.7 to 85.8
Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Overall survival rate at 12 months	68.4 percentage of participants Interval 51.0 to 80.7	55.4 percentage of participants Interval 37.2 to 70.3

SECONDARY outcome

Timeframe: From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months

Population: Best overall response and objective response rate were assessed in the Full Analysis Set.

The best overall response was defined as the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable. Based on RECIST v1.0, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	CS-7017 0.5 mg n=39 Participants Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo n=42 Participants Participants who were randomized to receive matching placebo.
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Confirmed CR	5 Participants	1 Participants
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Confirmed PR	1 Participants	0 Participants
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Objective response (confirmed CR+PR)	6 Participants	1 Participants
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Unconfirmed CR	0 Participants	0 Participants
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Unconfirmed PR	0 Participants	3 Participants
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Stable disease	10 Participants	8 Participants
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Progressive disease	20 Participants	27 Participants
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Inevaluable	3 Participants	3 Participants
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Best overall response of SD or better	16 Participants	12 Participants

SECONDARY outcome

Timeframe: From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months

Population: Duration of response was assessed in the Full Analysis Set. Number Analyzed for each Row represents only the participants with CR or PR (confirmed and unconfirmed) and SD.

Duration of response was defined for participants with confirmed CR or PR and confirmed and unconfirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease. Duration of response was estimated using Kaplan Meier methods.

Outcome measures

Outcome measures
Measure	CS-7017 0.5 mg n=39 Participants Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo n=42 Participants Participants who were randomized to receive matching placebo.
Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Duration of response (confirmed responses)	33.57 weeks Standard Deviation 25.88	37.86 weeks Standard Deviation NA SD could not be calculated on a single participant.
Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Duration of response (confirmed and unconfirmed)	33.57 weeks Standard Deviation 25.88	15.96 weeks Standard Deviation 14.86
Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Duration of stable disease	26.16 weeks Standard Deviation 10.68	22.52 weeks Standard Deviation 8.01

SECONDARY outcome

Timeframe: Baseline up to 30 days after last study dose, up to 3 years 3 months

Population: Adverse events were assessed in the Safety Analysis Set.

A treatment-emergent adverse event (TEAE) was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.

Outcome measures

Outcome measures
Measure	CS-7017 0.5 mg n=41 Participants Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo n=42 Participants Participants who were randomized to receive matching placebo.
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Any Related TEAE	37 Participants	16 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Any Blood and Lymphatic System Disorder	7 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Anaemia	6 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Any General Disorder& Administration Site Disorder	23 Participants	6 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Face oedema	4 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Fatigue	6 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Localised oedema	3 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Oedema	3 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Oedema peripheral	16 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Any Gastrointestinal Disorder	6 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Any Investigations	22 Participants	7 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Any Skin and Subcutaneous Tissue Disorder	5 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Weight increased	20 Participants	5 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Any Metabolism and Nutrition Disorder	6 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Fluid retention	5 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Any Respiratory, Thoracic, & Mediastinal Disorder	8 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Dyspnoea	4 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy Pleural effusion	3 Participants	0 Participants

Adverse Events

CS-7017 0.5 mg

Serious events: 6 serious events

Other events: 41 other events

Deaths: 16 deaths

Placebo

Serious events: 5 serious events

Other events: 31 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	CS-7017 0.5 mg n=41 participants at risk Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day.	Placebo n=42 participants at risk Participants who were randomized to receive matching placebo.
Blood and lymphatic system disorders Anaemia	7.3% 3/41 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.	4.8% 2/42 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.
Gastrointestinal disorders Ileus	2.4% 1/41 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.
Gastrointestinal disorders Peritonitis	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.	2.4% 1/42 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.
General disorders Generalised oedema	2.4% 1/41 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.
Skin and subcutaneous tissue disorders Purpura	2.4% 1/41 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set. A TEAE was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.

Other adverse events

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place