Trial Outcomes & Findings for CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC) (NCT NCT01199055)

NCT ID: NCT01199055

Last Updated: 2020-07-07

Results Overview

The area under the concentration versus time curve during dosing interval (AUCtau) and up to the last quantifiable time (AUClast) of geometric means of CS-7017 are reported at selected cycles (C) and days (D).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose

Results posted on

2020-07-07

Participant Flow

A total of 18 participants were screened for eligibility. Of the 18 participants who were screened, 16 participants who met all inclusion criteria and no exclusion criteria were enrolled from 17 March 2010 to 15 April 2011 at 1 site in South Korea. All 16 participants received treatment.

This dose-escalating study included an initial and additional portion. Participants received CS-7017 combination treatment with carboplatin \& paclitaxel (starting dose 0.25 mg twice daily \[BID\] in the initial portion). In the additional portion, the CS-7017 dose was determined (0.50 mg BID) based on the initial portion.

Participant milestones

Participant milestones
Measure	CS-7017 0.25 mg BID; Initial Portion Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel
Overall Study STARTED	3	4	9
Overall Study COMPLETED	1	1	5
Overall Study NOT COMPLETED	2	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	CS-7017 0.25 mg BID; Initial Portion Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel
Overall Study Death	0	1	0
Overall Study Physician Decision	0	1	1
Overall Study Progressive disease	2	1	2
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CS-7017 0.25 mg BID; Initial Portion n=3 Participants Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion n=4 Participants Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion n=9 Participants Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel	Total n=16 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	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Age, Continuous	59.7 years STANDARD_DEVIATION 9.29 • n=5 Participants	62.3 years STANDARD_DEVIATION 5.91 • n=7 Participants	58.9 years STANDARD_DEVIATION 9.98 • n=5 Participants	59.9 years STANDARD_DEVIATION 8.59 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment South Korea	3 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants	16 participants n=4 Participants

PRIMARY outcome

Timeframe: Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Outcome measures

Outcome measures
Measure	CS-7017 0.25 mg BID; Initial Portion n=3 Participants Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion n=4 Participants Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion n=9 Participants Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel	CS71017 0.5 mg BID; Initial and Additional Portion All participants who received 0.5 mg twice daily CS-7017 in combination with carboplatin and paclitaxel during either the initial or additional portion.	Overall All participants who received CS-7017 in combination with carboplatin and paclitaxel.
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Cycle 1, Week 1: AUCtau	70.66 ng*h/mL Standard Deviation 54.11	209.33 ng*h/mL Standard Deviation 131.40	203.99 ng*h/mL Standard Deviation 91.34	—	—
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Cycle 1, Week 1: AUClast	49.57 ng*h/mL Standard Deviation 36.86	87.23 ng*h/mL Standard Deviation 85.69	81.54 ng*h/mL Standard Deviation 66.01	—	—
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Cycle 2, Week 4: AUCtau	132.47 ng*h/mL Standard Deviation 25.49	345.56 ng*h/mL Standard Deviation 156.29	400.89 ng*h/mL Standard Deviation 212.22	—	—
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Cycle 2, Week 4: AUClast	95.94 ng*h/mL Standard Deviation 15.84	240.61 ng*h/mL Standard Deviation 107.09	268.00 ng*h/mL Standard Deviation 134.40	—	—

PRIMARY outcome

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).

Outcome measures

Outcome measures
Measure	CS-7017 0.25 mg BID; Initial Portion n=3 Participants Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion n=4 Participants Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion n=9 Participants Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel	CS71017 0.5 mg BID; Initial and Additional Portion All participants who received 0.5 mg twice daily CS-7017 in combination with carboplatin and paclitaxel during either the initial or additional portion.	Overall All participants who received CS-7017 in combination with carboplatin and paclitaxel.
Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Cycle 1, Week 1: Cmax	8.90 ng/mL Standard Deviation 7.01	15.98 ng/mL Standard Deviation 16.77	14.54 ng/mL Standard Deviation 9.75	—	—
Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Cycle 2, Week 4: Cmax,ss	13.63 ng/mL Standard Deviation 1.77	33.83 ng/mL Standard Deviation 15.42	39.58 ng/mL Standard Deviation 18.63	—	—

PRIMARY outcome

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).

Outcome measures

Outcome measures
Measure	CS-7017 0.25 mg BID; Initial Portion n=3 Participants Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion n=3 Participants Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion n=9 Participants Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel	CS71017 0.5 mg BID; Initial and Additional Portion All participants who received 0.5 mg twice daily CS-7017 in combination with carboplatin and paclitaxel during either the initial or additional portion.	Overall All participants who received CS-7017 in combination with carboplatin and paclitaxel.
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Cycle 1, Week 1: Tmax	3.90 h Interval 1.98 to 3.95	3.00 h Interval 2.92 to 6.05	5.95 h Interval 2.0 to 8.1	—	—
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Cycle 2, Week 4: Tmax,ss	3.17 h Interval 3.02 to 4.08	3.98 h Interval 2.9 to 4.12	3.88 h Interval 1.95 to 6.02	—	—

PRIMARY outcome

Timeframe: Baseline to end of Cycle 1, with each treatment cycle being 3 weeks

Population: TEAEs were assessed in the Safety Analysis Set.

Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug.

Outcome measures

Outcome measures
Measure	CS-7017 0.25 mg BID; Initial Portion n=3 Participants Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion n=4 Participants Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion n=9 Participants Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel	CS71017 0.5 mg BID; Initial and Additional Portion All participants who received 0.5 mg twice daily CS-7017 in combination with carboplatin and paclitaxel during either the initial or additional portion.	Overall All participants who received CS-7017 in combination with carboplatin and paclitaxel.
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Pruritus	0 Participants	2 Participants	1 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer General Disorders & Administration Site Conditions	3 Participants	1 Participants	5 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Musculoskeletal and Connective Tissue Disorders	3 Participants	2 Participants	7 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Myalgia	2 Participants	0 Participants	6 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Athralgia	1 Participants	2 Participants	0 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Fatigue	3 Participants	0 Participants	1 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Investigations	0 Participants	2 Participants	8 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Weight increased	0 Participants	2 Participants	7 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer At least one TEAE	3 Participants	4 Participants	9 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Blood and lymphatic system disorders	3 Participants	2 Participants	8 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Neutropenia	3 Participants	2 Participants	7 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Anaemia	0 Participants	0 Participants	5 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Metabolism and Nutrition Disorders	0 Participants	2 Participants	6 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Decreased appetite	0 Participants	1 Participants	6 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Nervous System Disorders	1 Participants	1 Participants	4 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Neuropathy peripheral	0 Participants	1 Participants	4 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Respiratory, Thoracic and Mediastinal Disorders	1 Participants	0 Participants	4 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Pleural effusion	0 Participants	0 Participants	4 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Gastrointestinal Disorders	2 Participants	1 Participants	6 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Nausea	2 Participants	1 Participants	1 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Skin and Subcutaneous Tissue Disorders	2 Participants	2 Participants	8 Participants	—	—
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer Alopecia	2 Participants	1 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 18 postdose

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

The best overall response is 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 from the start of treatment until the participant withdraws from the study. Participants who did not have a tumor assessment, the best overall response is Not Evaluable (NE). The response rate was defined as the proportion of participants with a best overall response of CR or PR, ie, \[confirmed and unconfirmed, (CR + PR) / number of participants\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions, PR was defined as ≥30% decrease in the sum of diameters of target lesions, PD was defined as ≥20 increase in the smallest sum of diameters, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	CS-7017 0.25 mg BID; Initial Portion n=3 Participants Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion n=3 Participants Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion n=8 Participants Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel	CS71017 0.5 mg BID; Initial and Additional Portion n=11 Participants All participants who received 0.5 mg twice daily CS-7017 in combination with carboplatin and paclitaxel during either the initial or additional portion.	Overall n=14 Participants All participants who received CS-7017 in combination with carboplatin and paclitaxel.
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Complete response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Partial response (PR)	0 Participants	2 Participants	4 Participants	6 Participants	6 Participants
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Stable disease (SD)	1 Participants	0 Participants	2 Participants	2 Participants	3 Participants
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Progressive disease (PD)	2 Participants	1 Participants	2 Participants	3 Participants	5 Participants
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Not evaluable (NE)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Response rate (CR + PR)	0 Participants	2 Participants	4 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline to 30 days after last dose, up to approximately 1 year

Population: CS-7017-related TEAEs were assessed in the Safety Analysis Set.

Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. CS-7017-related TEAEs are those TEAEs that are related to CS-7017 in the relationship.

Outcome measures

Outcome measures
Measure	CS-7017 0.25 mg BID; Initial Portion n=3 Participants Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion n=4 Participants Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion n=9 Participants Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel	CS71017 0.5 mg BID; Initial and Additional Portion All participants who received 0.5 mg twice daily CS-7017 in combination with carboplatin and paclitaxel during either the initial or additional portion.	Overall All participants who received CS-7017 in combination with carboplatin and paclitaxel.
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer At least one CS-7017-related TEAE	2 Participants	3 Participants	8 Participants	—	—
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer Respiratory, Thoracic and Mediastinal Disorders	0 Participants	1 Participants	4 Participants	—	—
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer Pleural effusion	0 Participants	1 Participants	4 Participants	—	—
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer General Disorders & Administration Site Conditions	1 Participants	2 Participants	7 Participants	—	—
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer Face oedema	1 Participants	2 Participants	4 Participants	—	—
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer Oedema peripheral	0 Participants	2 Participants	3 Participants	—	—
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer Investigations	1 Participants	3 Participants	8 Participants	—	—
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer Weight increased	1 Participants	3 Participants	8 Participants	—	—

Adverse Events

CS-7017 0.25 mg BID; Initial Portion

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

CS-7017 0.50 mg BID; Initial Portion

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

CS-7017 0.50 mg BID; Additional Portion

Serious events: 6 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CS-7017 0.25 mg BID; Initial Portion n=3 participants at risk Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Initial Portion n=4 participants at risk Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.	CS-7017 0.50 mg BID; Additional Portion n=9 participants at risk Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel
General disorders Pyrexia	0.00% 0/3 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/4 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	22.2% 2/9 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/4 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	22.2% 2/9 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.
Investigations Weight increased	0.00% 0/3 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/4 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	11.1% 1/9 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.
Infections and infestations Pneumonia klebsiella	0.00% 0/3 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/4 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	11.1% 1/9 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/4 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	22.2% 2/9 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.
General disorders Chest pain	0.00% 0/3 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/4 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	11.1% 1/9 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/4 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	11.1% 1/9 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.
Infections and infestations Septic shock	0.00% 0/3 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	25.0% 1/4 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/9 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.
Cardiac disorders Pericardial effusion	33.3% 1/3 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/4 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the study drug.	0.00% 0/9 • Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year. Adverse events 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 the 30 days after the last dose of the 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