Trial Outcomes & Findings for A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel (NCT NCT00603941)

Last Updated: 2020-09-16

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

PHASE1/PHASE2

Target enrollment

19 participants

Primary outcome timeframe

From baseline up to disease progression or death, up to approximately 2 years postdose

Results posted on

2020-09-16

Participant Flow

A total of 19 participants who met all inclusion and no exclusion criteria were enrolled in the study; 15 received treatment. Due to low enrollment, no participant had a dose limiting toxicity, therefore a maximum tolerated dose required for the recommendation of Phase 2 dose could not be established. Therefore, the study was halted prematurely.

Sequential cohorts per dose level were treated with CS-7017 and paclitaxel in accordance with prospectively defined dose levels, dose escalation rules, and definitions of treatment-related dose-limiting toxicity (DLT).

Participant milestones

Participant milestones
Measure	Cohort 1; 0.15 mg CS-7017 Participants who received 0.15 mg twice daily (BID) oral CS-7017 and 135 \[Dose Level 1a\] or 175 \[Dose Level 1b\] mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 2; 0.30 mg CS-7017 Participants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 3; 0.50 mg CS-7017 Participants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.
Overall Study STARTED	7	10	2
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	7	10	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1; 0.15 mg CS-7017 Participants who received 0.15 mg twice daily (BID) oral CS-7017 and 135 \[Dose Level 1a\] or 175 \[Dose Level 1b\] mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 2; 0.30 mg CS-7017 Participants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 3; 0.50 mg CS-7017 Participants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.
Overall Study Disease progression	6	7	1
Overall Study Adverse Event	1	0	1
Overall Study Physician Decision	0	1	0
Overall Study Withdrawal by Subject	0	2	0

Baseline Characteristics

A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1; 0.15 mg CS-7017 n=7 Participants Participants who received 0.15 mg BID oral CS-7017 and 135 \[Dose Level 1a\] or 175 \[Dose Level 1b\] mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 2; 0.30 mg CS-7017 n=6 Participants Participants who received 0.30 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 3; 0.50 mg CS-7017 n=2 Participants Participants who received 0.50 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 12.79 • n=5 Participants	59.8 years STANDARD_DEVIATION 8.75 • n=7 Participants	73.5 years STANDARD_DEVIATION 0.71 • n=5 Participants	61.1 years STANDARD_DEVIATION 11.11 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	2 participants n=5 Participants	15 participants n=4 Participants

PRIMARY outcome

Timeframe: From baseline up to disease progression or death, up to approximately 2 years postdose

Population: PFS was assessed in the Efficacy Analysis Set. Since the study halted prematurely due to low enrollment and failed to establish a recommendation for a Phase 2 dose, it was not feasible to analyze the primary outcomes per arm. The arms were combined post hoc based on these circumstances and primary efficacy outcomes were assessed in all patients.

Outcome measures

Outcome measures
Measure	All Patients n=15 Participants All patients who received any dose of CS-7017 combined with paclitaxel chemotherapy.	Cohort 2; 0.30 mg CS-7017 Participants who received 0.30 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 3; 0.50 mg CS-7017 Participants who received 0.50 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.
Overall Progression-free Survival in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)	55.5 days Interval 29.0 to 71.0	—	—

PRIMARY outcome

Timeframe: From baseline up to date of death, up to approximately 2 years postdose

Overall survival (OS) was defined as the time from the date enrollment to the date of death.

Outcome measures

Outcome measures
Measure	All Patients n=15 Participants All patients who received any dose of CS-7017 combined with paclitaxel chemotherapy.	Cohort 2; 0.30 mg CS-7017 Participants who received 0.30 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 3; 0.50 mg CS-7017 Participants who received 0.50 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.
Overall Survival in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC)	130.0 days Interval 99.0 to 142.0	—	—

PRIMARY outcome

Timeframe: From baseline up to disease progression or the development of unacceptable toxicity, up to approximately 2 years postdose

The best overall response was the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no tumor assessment after the date of enrollment, the best overall response is classified as Unknown.

Outcome measures

Outcome measures
Measure	All Patients n=15 Participants All patients who received any dose of CS-7017 combined with paclitaxel chemotherapy.	Cohort 2; 0.30 mg CS-7017 Participants who received 0.30 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 3; 0.50 mg CS-7017 Participants who received 0.50 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.
Best Overall Response in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Confirmed complete response (CR)	0 Participants	—	—
Best Overall Response in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Confirmed partial response (PR)	1 Participants	—	—
Best Overall Response in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Objective response (confirmed CR + PR)	1 Participants	—	—
Best Overall Response in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Stable disease	8 Participants	—	—
Best Overall Response in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Progressive disease	4 Participants	—	—
Best Overall Response in Participants After a Dosage of CS-7017 Administered Twice Daily in Combination With Paclitaxel Administered Once Every 3 Weeks to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Unknown	2 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to 30 days after last dose, up to approximately 2 years

Population: TEAEs were assessed in the Safety Analysis Set.

Treatment-emergent adverse events (TEAEs) are defined as adverse events that started or worsened after the first dose of any study drug (after Day 1 or first day of CS-7017 monotherapy) but adverse events occurring more than 30 days after the last dose are not considered TEAEs unless also considered to be related (possibly, probably, or definitely) to study drug.

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants All patients who received any dose of CS-7017 combined with paclitaxel chemotherapy.	Cohort 2; 0.30 mg CS-7017 n=6 Participants Participants who received 0.30 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 3; 0.50 mg CS-7017 n=2 Participants Participants who received 0.50 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Neutrophil count decreased	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Any Severe TEAE of Grade ≥3	3 Participants	5 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Anaemia	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Dysphagia	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Disease progression	2 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Anaphylatic reaction	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Pneumonia	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Septic shock	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Loss of consciousness	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events, Summarized by Worst CTCAE Grade (≥3) and Preferred Term After Administration of CS-7017 Combined With Paclitaxel Administered to Participants With Advanced Anaplastic Thyroid Cancer (ATC) Dyspnoea	0 Participants	1 Participants	0 Participants

Adverse Events

Cohort 1; 0.15 mg CS-7017

Serious events: 3 serious events

Other events: 6 other events

Deaths: 6 deaths

Cohort 2; 0.30 mg CS-7017

Serious events: 3 serious events

Other events: 6 other events

Deaths: 6 deaths

Cohort 3; 0.50 mg CS-7017

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1; 0.15 mg CS-7017 n=7 participants at risk Participants who received 0.15 mg BID oral CS-7017 and 135 \[Dose Level 1a\] or 175 \[Dose Level 1b\] mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 2; 0.30 mg CS-7017 n=6 participants at risk Participants who received 0.30 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.	Cohort 3; 0.50 mg CS-7017 n=2 participants at risk Participants who received 0.50 mg BID oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.
Psychiatric disorders Confusional state	14.3% 1/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Septic shock	14.3% 1/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Disease progression	28.6% 2/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Dysphagia	14.3% 1/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Clostridial infection	0.00% 0/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	16.7% 1/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Pneumonia	0.00% 0/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	16.7% 1/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	16.7% 1/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	16.7% 1/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Nervous system disorders Loss of consciousness	0.00% 0/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	50.0% 1/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Immune system disorders Anaphylatic reaction	0.00% 0/7 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/6 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	50.0% 1/2 • Treatment-emergent adverse event data were collected from baseline up to 30 days after last dose, up to approximately 2 years. Adverse events (AEs) were 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. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study 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