Trial Outcomes & Findings for A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer (NCT NCT00352690)

NCT ID: NCT00352690

Last Updated: 2016-12-12

Results Overview

* OS = time from patient registration to death of all causes * Estimated using Kaplan Meier

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2016-12-12

Participant Flow

Enrollment to the study was opened on 04/05/2006 and enrollment to the study closed 06/30/2008.

Participant milestones

Participant milestones
Measure	Cohort 1 (First 12 Eligible Patients) Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Overall Study STARTED	10	0
Overall Study COMPLETED	8	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (First 12 Eligible Patients) Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Overall Study Determined to be ineligible	2	0

Baseline Characteristics

A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (First 12 Eligible Patients) n=8 Participants Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Total n=8 Participants Total of all reporting groups
Age, Continuous	69 years n=5 Participants	—	69 years n=5 Participants
Gender Female	5 Participants n=5 Participants	—	—
Gender Male	3 Participants n=5 Participants	—	—
Region of Enrollment United States	8 participants n=5 Participants	—	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants with unknown expiration dates were censored at the date of last clinical contact.

* OS = time from patient registration to death of all causes * Estimated using Kaplan Meier

Outcome measures

Outcome measures
Measure	Cohort 1 (First 12 Eligible Patients) n=8 Participants Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Overall Survival (OS) Rate	73 percentage of participants	—

PRIMARY outcome

Timeframe: Completion of follow-up (follow-up ranged from 3 months to 6 years)

Population: Participants with unknown expiration dates were censored at the date of last clinical contact.

OS = time from patient registration to death of all causes

Outcome measures

Outcome measures
Measure	Cohort 1 (First 12 Eligible Patients) n=8 Participants Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Overall Survival (OS)	10.4 months Interval 3.5 to 18.5	—

SECONDARY outcome

Timeframe: 6 months

Population: Participants with unknown event dates were censored at the date of last clinical contact.

* The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first) * Estimated using Kaplan Meier

Outcome measures

Outcome measures
Measure	Cohort 1 (First 12 Eligible Patients) n=8 Participants Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Failure-free Survival (FFS) Rate	44 percentage of participants	—

SECONDARY outcome

Timeframe: Completion of follow-up (follow-up ranged from 3 months to 6 years)

Population: Participants with unknown event dates were censored at the date of last clinical contact.

The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)

Outcome measures

Outcome measures
Measure	Cohort 1 (First 12 Eligible Patients) n=8 Participants Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Failure-free Survival (FFS)	6 months Interval 3.5 to 10.4	—

SECONDARY outcome

Timeframe: 4 years

Overall best response using RECIST 1.0

Outcome measures

Outcome measures
Measure	Cohort 1 (First 12 Eligible Patients) n=8 Participants Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Response Rates Complete response	1 participants	—
Response Rates Partial response	5 participants	—
Response Rates Progressive disease	1 participants	—
Response Rates Unknown	1 participants	—

SECONDARY outcome

Timeframe: 30 days following completion of treatment (approximately 114 days)

Population: Using CTCAE Version 3.0

Outcome measures

Outcome measures
Measure	Cohort 1 (First 12 Eligible Patients) n=8 Participants Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Incidence and Severity of Radiation-induced Esophagitis Grade 1	1 participants	—
Incidence and Severity of Radiation-induced Esophagitis Grade 2	3 participants	—
Incidence and Severity of Radiation-induced Esophagitis Grade 3	0 participants	—
Incidence and Severity of Radiation-induced Esophagitis Grade 4	0 participants	—
Incidence and Severity of Radiation-induced Esophagitis Grade 5	0 participants	—

SECONDARY outcome

Timeframe: 30 days following completion of treatment (approximately 114 days)

Population: Using CTCAE Version 3.0.

Outcome measures

Outcome measures
Measure	Cohort 1 (First 12 Eligible Patients) n=8 Participants Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Incidence and Severity of Radiation-induced Pneumonitis Grade 1	1 participants	—
Incidence and Severity of Radiation-induced Pneumonitis Grade 2	2 participants	—
Incidence and Severity of Radiation-induced Pneumonitis Grade 3	1 participants	—
Incidence and Severity of Radiation-induced Pneumonitis Grade 4	0 participants	—
Incidence and Severity of Radiation-induced Pneumonitis Grade 5	0 participants	—

Adverse Events

Cohort 1 (First 12 Eligible Patients)

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 2 (Remaining Patients)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Ramaswamy Govindan, M.D.

Washington University School of Medicine

Phone: 314-362-5737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1 (First 12 Eligible Patients) n=8 participants at risk Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.	Cohort 2 (Remaining Patients) Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Metabolism and nutrition disorders Anorexia	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Respiratory, thoracic and mediastinal disorders Aspiration	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Cardiac disorders Atrial fibrillation	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
General disorders Death NOS	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Metabolism and nutrition disorders Dehydration	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Gastrointestinal disorders Dysphagia	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Nervous system disorders Encephalopathy	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
General disorders Fatigue	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Infections and infestations Febrile neutropenia	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Cardiac disorders Hypotension	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Gastrointestinal disorders Ileus	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Investigations Leukocytes (WBC)	25.0% 2/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Metabolism and nutrition disorders Metabolic acidosis	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Investigations Myoglobin	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Investigations Neutrophils	37.5% 3/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Investigations PTT	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Respiratory, thoracic and mediastinal disorders Radiation pneumonitis	25.0% 2/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Renal and urinary disorders Renal failure	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Respiratory, thoracic and mediastinal disorders Respiratory failure (death)	25.0% 2/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Infections and infestations Sepsis	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Cardiac disorders Troponin	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
Infections and infestations Urinary tract infection	12.5% 1/8 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)	— 0/0 • Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)