Trial Outcomes & Findings for Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer (NCT NCT00243867)

Last Updated: 2025-08-01

Results Overview

Overall survival was defined as the time from the day of randomization and ends at death of the participant. Participants were followed every 2 months, whether on or off study, for survival information. Participants alive at the time of termination of the study were considered censored.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

518 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2025-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Taxoprexin® and Carboplatin Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion
Overall Study STARTED	260	258
Overall Study COMPLETED	84	84
Overall Study NOT COMPLETED	176	174

Reasons for withdrawal

Reasons for withdrawal
Measure	Taxoprexin® and Carboplatin Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion
Overall Study Adverse Event	24	34
Overall Study Lack of Efficacy	115	78
Overall Study Withdrawal by Subject	11	23
Overall Study Lost to Follow-up	2	1
Overall Study Physician Decision	2	7
Overall Study Delayed treatment, omission of treatment, peripheral neuropathy, intercurrent illness	22	31

Baseline Characteristics

One participants weight is missing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Taxoprexin® and Carboplatin n=260 Participants Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin n=258 Participants Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion	Total n=518 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 9.35 • n=260 Participants	62.4 years STANDARD_DEVIATION 10.54 • n=258 Participants	62.8 years STANDARD_DEVIATION 9.96 • n=518 Participants
Sex: Female, Male Female	81 Participants n=260 Participants	68 Participants n=258 Participants	149 Participants n=518 Participants
Sex: Female, Male Male	179 Participants n=260 Participants	190 Participants n=258 Participants	369 Participants n=518 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=260 Participants	0 Participants n=258 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Asian	1 Participants n=260 Participants	1 Participants n=258 Participants	2 Participants n=518 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=260 Participants	0 Participants n=258 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Black or African American	10 Participants n=260 Participants	13 Participants n=258 Participants	23 Participants n=518 Participants
Race (NIH/OMB) White	249 Participants n=260 Participants	244 Participants n=258 Participants	493 Participants n=518 Participants
Race (NIH/OMB) More than one race	0 Participants n=260 Participants	0 Participants n=258 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=260 Participants	0 Participants n=258 Participants	0 Participants n=518 Participants
Region of Enrollment United States	161 Participants n=260 Participants	163 Participants n=258 Participants	324 Participants n=518 Participants
Region of Enrollment Russia	50 Participants n=260 Participants	49 Participants n=258 Participants	99 Participants n=518 Participants
Region of Enrollment Ukraine	49 Participants n=260 Participants	46 Participants n=258 Participants	95 Participants n=518 Participants
Disease Stage IIIb	57 Participants n=260 Participants	53 Participants n=258 Participants	110 Participants n=518 Participants
Disease Stage IV	203 Participants n=260 Participants	205 Participants n=258 Participants	408 Participants n=518 Participants
Weight	73.88 kilograms STANDARD_DEVIATION 15.111 • n=260 Participants • One participants weight is missing	75.46 kilograms STANDARD_DEVIATION 17.567 • n=257 Participants • One participants weight is missing	74.67 kilograms STANDARD_DEVIATION 16.378 • n=517 Participants • One participants weight is missing

PRIMARY outcome

Timeframe: Up to 12 months

Population: Intent to treat

Outcome measures

Outcome measures
Measure	Taxoprexin® and Carboplatin n=260 Participants Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin n=258 Participants Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion
Overall Survival	8.31 Months Interval 7.0 to 9.89	8.51 Months Interval 7.82 to 9.69

SECONDARY outcome

Timeframe: Assessed every 6 weeks, up to 12 months

Population: Intent to treat

Antitumor response was defined as the percentage of participants who achieved an objective response (Complete Response or Partial Response), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart.

Outcome measures

Outcome measures
Measure	Taxoprexin® and Carboplatin n=260 Participants Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin n=258 Participants Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion
Percentage of Participants Who Achieved an Objective Complete Response or Partial Response	40 Participants	95 Participants

SECONDARY outcome

Timeframe: Assessed every 6 weeks, up to 12 months

Population: Intent to treat

Duration of overall response was a measurement from the time measure criteria was met for confirmed complete response or partial response (whichever was first recorded) until the first date that recurrent of progressive disease was objectively documented (taking as reference for progressive disease the smallest measurement recorded since treatment started).

Outcome measures

Outcome measures
Measure	Taxoprexin® and Carboplatin n=40 Participants Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin n=95 Participants Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion
Duration of Response	5.75 Months Interval 5.09 to 8.54	5.35 Months Interval 3.98 to 6.21

SECONDARY outcome

Timeframe: Up to 12 months

Population: Intent to treat

TTP was defined as the time from randomization to documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since treatment start or the appearance of 1 or more lesions.

Outcome measures

Outcome measures
Measure	Taxoprexin® and Carboplatin n=260 Participants Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin n=258 Participants Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion
Time to Progression (TTP)	3.02 Months Interval 2.66 to 4.01	4.47 Months Interval 3.04 to 5.22

SECONDARY outcome

Timeframe: Baseline to stopping treatment, up to 12 months

Population: Intent to treat

TTF is defined as the time from randomization to the discontinuation of protocol treatment for any reason

Outcome measures

Outcome measures
Measure	Taxoprexin® and Carboplatin n=260 Participants Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin n=258 Participants Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion
Time to Treatment Failure (TTF)	2.79 Months Interval 2.1 to 3.02	3.25 Months Interval 2.89 to 3.78

Adverse Events

Taxoprexin® and Carboplatin

Serious events: 70 serious events

Other events: 235 other events

Deaths: 198 deaths

Paclitaxel and Carboplatin

Serious events: 91 serious events

Other events: 239 other events

Deaths: 196 deaths

Serious adverse events

Other adverse events

Additional Information

Manager Medical Writing

American Regent Inc.

Phone: 631-772-3555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Taxoprexin® and Carboplatin n=256 participants at risk Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin n=251 participants at risk Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic, and mediastinal disorders	8.2% 21/256 • Number of events 21 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	7.2% 18/251 • Number of events 18 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Dyspenea	2.3% 6/256 • Number of events 6 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	2.4% 6/251 • Number of events 6 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.2% 3/256 • Number of events 3 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	0.80% 2/251 • Number of events 2 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 3/256 • Number of events 3 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	0.00% 0/251 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.78% 2/256 • Number of events 2 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	1.2% 3/251 • Number of events 3 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	0.78% 2/256 • Number of events 2 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	1.2% 3/251 • Number of events 3 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.39% 1/256 • Number of events 1 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	1.2% 3/251 • Number of events 3 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
General disorders General disorders and administration site conditions	6.2% 16/256 • Number of events 16 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	7.6% 19/251 • Number of events 19 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
General disorders Disease progression	4.3% 11/256 • Number of events 11 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	3.6% 9/251 • Number of events 9 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
General disorders Asthenia	0.78% 2/256 • Number of events 2 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	1.6% 4/251 • Number of events 4 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Infections and infestations Infections and infestations	5.5% 14/256 • Number of events 14 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	8.4% 21/251 • Number of events 21 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Infections and infestations Infection	0.00% 0/256 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	1.2% 3/251 • Number of events 3 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Infections and infestations Pneumonia	2.3% 6/256 • Number of events 6 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	4.4% 11/251 • Number of events 11 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Cardiac disorders Cardiac disorders	2.3% 6/256 • Number of events 6 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	4.0% 10/251 • Number of events 10 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Cardiac disorders Atrial fibrillation	1.2% 3/256 • Number of events 3 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	0.40% 1/251 • Number of events 1 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Gastrointestinal disorders Gastrointestinal disorders	2.7% 7/256 • Number of events 7 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	2.4% 6/251 • Number of events 6 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Metabolism and nutrition disorders Metabolism and nutrition disorders	2.3% 6/256 • Number of events 6 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	4.0% 10/251 • Number of events 10 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Metabolism and nutrition disorders Dehydration	2.0% 5/256 • Number of events 5 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	3.2% 8/251 • Number of events 8 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Nervous system disorders Nervous system disorders	0.78% 2/256 • Number of events 2 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	4.8% 12/251 • Number of events 12 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Vascular disorders Vascular disorders	2.0% 5/256 • Number of events 5 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	1.6% 4/251 • Number of events 4 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	1.2% 3/256 • Number of events 3 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	2.0% 5/251 • Number of events 5 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Blood and lymphatic system disorders Febrile neutropenia	0.39% 1/256 • Number of events 1 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	2.0% 5/251 • Number of events 5 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Psychiatric disorders Psychiatric disorders	0.39% 1/256 • Number of events 1 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	2.0% 5/251 • Number of events 5 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.

Other adverse events
Measure	Taxoprexin® and Carboplatin n=256 participants at risk Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. Taxoprexin: Administered by intravenous infusion over 1 hour infusion Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25).	Paclitaxel and Carboplatin n=251 participants at risk Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles. Carboplatin: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). Paclitaxel: Administered by intravenous infusion over 3 hour infusion
General disorders Fatigue	39.5% 101/256 • Number of events 101 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	36.7% 92/251 • Number of events 92 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
General disorders Edema peripheral	14.1% 36/256 • Number of events 36 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	12.7% 32/251 • Number of events 32 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
General disorders Asthenia	11.3% 29/256 • Number of events 29 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	21.5% 54/251 • Number of events 54 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
General disorders Non-cardiac chest pain	8.2% 21/256 • Number of events 21 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	9.2% 23/251 • Number of events 23 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
General disorders Pyrexia	5.5% 14/256 • Number of events 14 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	5.2% 13/251 • Number of events 13 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
General disorders Pain	2.7% 7/256 • Number of events 7 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	5.6% 14/251 • Number of events 14 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Gastrointestinal disorders Nausea	35.5% 91/256 • Number of events 91 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	37.5% 94/251 • Number of events 94 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Gastrointestinal disorders Constipation	24.6% 63/256 • Number of events 63 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	27.5% 69/251 • Number of events 69 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Gastrointestinal disorders Vomiting	14.5% 37/256 • Number of events 37 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	18.3% 46/251 • Number of events 46 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Gastrointestinal disorders Diarrhea	12.1% 31/256 • Number of events 31 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	16.7% 42/251 • Number of events 42 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Gastrointestinal disorders Abdominal pain	5.1% 13/256 • Number of events 13 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	7.2% 18/251 • Number of events 18 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Gastrointestinal disorders Dyspepsia	5.1% 13/256 • Number of events 13 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	5.6% 14/251 • Number of events 14 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Dyspenia	21.9% 56/256 • Number of events 56 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	23.1% 58/251 • Number of events 58 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Cough	14.5% 37/256 • Number of events 37 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	15.9% 40/251 • Number of events 40 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.2% 16/256 • Number of events 16 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	2.4% 6/251 • Number of events 6 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Hemoptysis	5.1% 13/256 • Number of events 13 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	4.4% 11/251 • Number of events 11 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Nervous system disorders Dizziness	11.3% 29/256 • Number of events 29 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	11.6% 29/251 • Number of events 29 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Nervous system disorders Headache	9.8% 25/256 • Number of events 25 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	7.6% 19/251 • Number of events 19 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Nervous system disorders Neuropathy peripheral	9.0% 23/256 • Number of events 23 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	21.5% 54/251 • Number of events 54 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Nervous system disorders Peripheral sensory neuropathy	7.0% 18/256 • Number of events 18 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	25.1% 63/251 • Number of events 63 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Dysgeusia	3.5% 9/256 • Number of events 9 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	8.0% 20/251 • Number of events 20 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Nervous system disorders Neuropathy	3.1% 8/256 • Number of events 8 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	9.2% 23/251 • Number of events 23 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Musculoskeletal and connective tissue disorders Back pain	10.5% 27/256 • Number of events 27 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	5.6% 14/251 • Number of events 14 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	8.6% 22/256 • Number of events 22 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	19.5% 49/251 • Number of events 49 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	7.0% 18/256 • Number of events 18 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	6.8% 17/251 • Number of events 17 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Musculoskeletal and connective tissue disorders Myalgia	4.3% 11/256 • Number of events 11 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	12.0% 30/251 • Number of events 30 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Musculoskeletal and connective tissue disorders Chest wall pain	5.1% 13/256 • Number of events 13 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	4.0% 10/251 • Number of events 10 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Musculoskeletal and connective tissue disorders Bone pain	2.3% 6/256 • Number of events 6 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	8.8% 22/251 • Number of events 22 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	5.1% 13/256 • Number of events 13 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	4.0% 10/251 • Number of events 10 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.9% 10/256 • Number of events 10 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	6.8% 17/251 • Number of events 17 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Skin and subcutaneous tissue disorders Alopecia	9.4% 24/256 • Number of events 24 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	49.4% 124/251 • Number of events 124 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Skin and subcutaneous tissue disorders Rash	5.9% 15/256 • Number of events 15 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	6.8% 17/251 • Number of events 17 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Metabolism and nutrition disorders Anorexia	14.8% 38/256 • Number of events 38 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	19.5% 49/251 • Number of events 49 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Metabolism and nutrition disorders Dehydration	5.5% 14/256 • Number of events 14 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	11.6% 29/251 • Number of events 29 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Psychiatric disorders Insomnia	10.9% 28/256 • Number of events 28 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	12.7% 32/251 • Number of events 32 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Psychiatric disorders Anxiety	4.3% 11/256 • Number of events 11 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	5.2% 13/251 • Number of events 13 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Psychiatric disorders Depression	3.5% 9/256 • Number of events 9 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	8.0% 20/251 • Number of events 20 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.
Investigations Weight decreased	7.4% 19/256 • Number of events 19 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.	13.1% 33/251 • Number of events 33 • Day of initial treatment with study drug until 30 days after last treatment, up to 12 months An adverse event was defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The Safety Set was the population used to evaluate adverse events.