Trial Outcomes & Findings for FOLFOX-A in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma (NCT NCT03283761)

Last Updated: 2024-02-06

Results Overview

Objective response rate will be calculated by combining the number of subjects who achieve complete response and partial response per RECIST 1.1 criteria.Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

From C1D1 until death or up to a maximum of 36 months

Results posted on

2024-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Nab-paclitaxel and FOLFOX-A All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Study Treatment STARTED	39
Study Treatment COMPLETED	0
Study Treatment NOT COMPLETED	39
Follow up STARTED	38
Follow up COMPLETED	0
Follow up NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Nab-paclitaxel and FOLFOX-A All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Study Treatment Patient Non-Compliance	1
Study Treatment Alternative Cancer Therapy	7
Study Treatment Disease progression	21
Study Treatment Adverse Event	3
Study Treatment Withdrawal by Subject	4
Study Treatment Pre-existing GI bleed and chronic anemia from that led to hospitalization and going off trial.	1
Study Treatment Symptomatic Deterioration	1
Study Treatment Screen Failure Before Therapy Start	1
Follow up Lost to Follow-up	1
Follow up Symptomatic Deterioration	1
Follow up Death	29
Follow up study terminated	4
Follow up Primary Investigator Withdrawal	1
Follow up Switched to alternative therapy	1
Follow up Subject is now in Hospice	1

Baseline Characteristics

FOLFOX-A in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-paclitaxel and FOLFOX-A n=39 Participants All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States · Fairview Southdale Cancer Clinic	1 Participants n=5 Participants
Region of Enrollment United States · M Health Fairview Clinics and Surgery Center	2 Participants n=5 Participants
Region of Enrollment United States · Northwestern Memorial Hospital	20 Participants n=5 Participants
Region of Enrollment United States · Rutgers Cancer Institute of New Jersey	2 Participants n=5 Participants
Region of Enrollment United States · University of Illinois Hospital and Health Systems (Outpatient Cancer Center)	2 Participants n=5 Participants
Region of Enrollment United States · University of Iowa Hospitals and Clinics	7 Participants n=5 Participants
Region of Enrollment United States · University of Wisconsin Clinical Science Center	5 Participants n=5 Participants
ECOG 0	20 Participants n=5 Participants
ECOG 1	19 Participants n=5 Participants
T Stage T3	13 Participants n=5 Participants
T Stage T4	5 Participants n=5 Participants
T Stage TX	19 Participants n=5 Participants
T Stage Unknown T stage	2 Participants n=5 Participants
T Stage N0	4 Participants n=5 Participants
T Stage N1	4 Participants n=5 Participants
T Stage N2	6 Participants n=5 Participants
T Stage N3	3 Participants n=5 Participants
T Stage NX	20 Participants n=5 Participants
T Stage Unknown N stage	2 Participants n=5 Participants
T Stage M0	2 Participants n=5 Participants
T Stage M1	35 Participants n=5 Participants
T Stage Unknown M stage	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From C1D1 until death or up to a maximum of 36 months

Population: 35 subjects out of 39 enrolled subjects were evaluable for objective response.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and FOLFOX-A n=35 Participants All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Objective Response Rate	15 Participants

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 52 months

Population: one subject out of 39 enrolled subject was a screen failure before start of therapy.

Overall survival is defined by the date of the start of treatment to date of death from any cause.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and FOLFOX-A n=38 Participants All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Overall Survival (OS)	10.6 months Interval 8.8 to 20.7

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 36 months

Population: one subject out of 39 enrolled subject was a screen failure before start of therapy.

Progression free survival is defined as the time of treatment initiation until the criteria for disease progression per RECIST1.1 are met or until the date of a death event (any cause). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and FOLFOX-A n=38 Participants All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Progression-Free Survival (PFS)	6.6 months Interval 5.7 to 12.9

SECONDARY outcome

Timeframe: From C1D1 until PD or up to a maximum of 36 months

Population: one subject out of 39 enrolled subject was a screen failure before start of therapy.

Time to progression is defined as the time from registration date until the criteria for disease progression per RECIST1.1 are met. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and FOLFOX-A n=38 Participants All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Time to Progression (TTP)	11.26 months Interval 5.68 to 26.65

SECONDARY outcome

Timeframe: From C1D1 until PD or up to a maximum of 36 months

Population: one subject out of 39 enrolled subject was a screen failure before start of therapy.

Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and FOLFOX-A n=38 Participants All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD Number of subjects with Complete Response as best RECIST response	1 Participants
Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD Number of subjects with Partial Response as best RECIST response	14 Participants
Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD Number of subjects with Stable Disease as best RECIST response	13 Participants
Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD Number of subjects with Progressive Disease as best RECIST response	7 Participants
Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD Number of subjects with no responses recorded	3 Participants

SECONDARY outcome

Timeframe: From C1D1 until PD or up to a maximum of 36 months

Population: 35 subjects out of 39 enrolled subjects were evaluable for response.

The disease control rate is the proportion of all subjects with stable disease (SD) , or partial response (PR), or complete response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. Stable disease is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and FOLFOX-A n=35 Participants All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Disease Control Rate (DCR)	80 percentage of participants

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 52 months

Population: one subject out of 39 enrolled subject was a screen failure before start of therapy.

Safety and tolerability of abemaciclib in the combination of nab-paclitaxel and FOLFOX in patients with metastatic or advanced unresectable gastric, gastro-esophageal junction adenocarcinoma., assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and FOLFOX-A n=38 Participants All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Safety and Toxicity Profile of the Combination of Nab-paclitaxel and FOLFOX Number of patients had at least one grade 3 or greater treatment related adverse event	32 Participants
Safety and Toxicity Profile of the Combination of Nab-paclitaxel and FOLFOX Number of patients having serious adverse event	21 Participants
Safety and Toxicity Profile of the Combination of Nab-paclitaxel and FOLFOX Number of patients had at least one adverse event of any toxicity grade	38 Participants
Safety and Toxicity Profile of the Combination of Nab-paclitaxel and FOLFOX Number of patients had at least one toxicity of grade 3 or greater adverse event	32 Participants

Adverse Events

Nab-paclitaxel and FOLFOX-A

Serious events: 22 serious events

Other events: 38 other events

Deaths: 29 deaths

Serious adverse events

Serious adverse events
Measure	Nab-paclitaxel and FOLFOX-A n=38 participants at risk All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Gastrointestinal disorders ABDOMINAL PAIN	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders ANEMIA	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders ATRIAL FLUTTER	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations BRONCHIAL INFECTION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders COLITIS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders DEHYDRATION	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders DEPRESSION	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DIARRHEA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders DIZZINESS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DYSPHAGIA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders ENCEPHALOPATHY	5.3% 2/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTRIC HEMORRHAGE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	2.6% 1/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders LOWER GASTROINTESTINAL HEMORRHAGE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations LUNG INFECTION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders MULTI-ORGAN FAILURE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders NAUSEA	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders OBSTRUCTION GASTRIC	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders PAIN	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders PERICARDIAL EFFUSION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders PERICARDITIS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders SEIZURE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations SEPSIS	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations SKIN INFECTION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders STROKE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders UPPER GASTROINTESTINAL HEMORRHAGE	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders VERTIGO	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders VOMITING	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Other adverse events

Other adverse events
Measure	Nab-paclitaxel and FOLFOX-A n=38 participants at risk All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
General disorders PAIN	28.9% 11/38 • Number of events 13 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	10.5% 4/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ABDOMINAL DISTENSION	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ABDOMINAL PAIN	39.5% 15/38 • Number of events 27 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders ACUTE KIDNEY INJURY	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders AKATHISIA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations ALANINE AMINOTRANSFERASE INCREASED	21.1% 8/38 • Number of events 21 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations ALKALINE PHOSPHATASE INCREASED	23.7% 9/38 • Number of events 28 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Immune system disorders ALLERGIC REACTION	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	15.8% 6/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders ALOPECIA	42.1% 16/38 • Number of events 18 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders AMNESIA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders ANEMIA	63.2% 24/38 • Number of events 67 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders ANOREXIA	60.5% 23/38 • Number of events 39 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders ANXIETY	36.8% 14/38 • Number of events 17 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders AORTIC VALVE DISEASE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders ARTHRITIS	15.8% 6/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ASCITES	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	21.1% 8/38 • Number of events 15 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders ATRIAL FLUTTER	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders BACK PAIN	21.1% 8/38 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders BLOATING	15.8% 6/38 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	10.5% 4/38 • Number of events 27 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations BLOOD BILIRUBIN INCREASED	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders BLURRED VISION	7.9% 3/38 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders BONE PAIN	10.5% 4/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications BRUISING	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders BUTTOCK PAIN	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders CARDIAC DISORDERS - OTHER, SPECIFY	13.2% 5/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations CATHETER RELATED INFECTION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders CHEST PAIN - CARDIAC	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders CHILLS	13.2% 5/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations CHOLESTEROL HIGH	13.2% 5/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders CHRONIC KIDNEY DISEASE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders COGNITIVE DISTURBANCE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders COLITIS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders CONCENTRATION IMPAIRMENT	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders CONFUSION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders CONSTIPATION	73.7% 28/38 • Number of events 44 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders COUGH	28.9% 11/38 • Number of events 13 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations CREATININE INCREASED	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders DEHYDRATION	21.1% 8/38 • Number of events 11 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders DELIRIUM	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DENTAL CARIES	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders DEPRESSION	13.2% 5/38 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations DEVICE RELATED INFECTION	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DIARRHEA	65.8% 25/38 • Number of events 50 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders DIZZINESS	28.9% 11/38 • Number of events 12 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DRY MOUTH	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders DRY SKIN	5.3% 2/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders DYSARTHRIA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders DYSGEUSIA	28.9% 11/38 • Number of events 13 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DYSPEPSIA	42.1% 16/38 • Number of events 18 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DYSPHAGIA	47.4% 18/38 • Number of events 24 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders DYSPHASIA	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders DYSPNEA	13.2% 5/38 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY	5.3% 2/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders EAR PAIN	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders EDEMA LIMBS	31.6% 12/38 • Number of events 13 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations ENDOCARDITIS INFECTIVE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	13.2% 5/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders ERYTHRODERMA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders EXTRAPYRAMIDAL DISORDER	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders EYE DISORDERS - OTHER, SPECIFY	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders FACIAL PAIN	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications FALL	13.2% 5/38 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders FATIGUE	84.2% 32/38 • Number of events 63 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders FEVER	28.9% 11/38 • Number of events 12 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders FLANK PAIN	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders FLU LIKE SYMPTOMS	7.9% 3/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders FLUSHING	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTRIC ULCER	5.3% 2/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTRITIS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	42.1% 16/38 • Number of events 17 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	28.9% 11/38 • Number of events 15 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTROINTESTINAL PAIN	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	5.3% 2/38 • Number of events 10 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	13.2% 5/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GINGIVAL PAIN	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders GLUCOSE INTOLERANCE	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders HALLUCINATIONS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders HEADACHE	15.8% 6/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders HEARING IMPAIRED	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders HEMATURIA	13.2% 5/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders HEMORRHOIDS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Hepatobiliary disorders HEPATOBILIARY DISORDERS - OTHER, SPECIFY	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders HICCUPS	7.9% 3/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders HOARSENESS	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERCALCEMIA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERGLYCEMIA	21.1% 8/38 • Number of events 12 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	10.5% 4/38 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERKALEMIA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERMAGNESEMIA	2.6% 1/38 • Number of events 10 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders HYPERTENSION	65.8% 25/38 • Number of events 73 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERURICEMIA	13.2% 5/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOALBUMINEMIA	23.7% 9/38 • Number of events 30 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOCALCEMIA	7.9% 3/38 • Number of events 11 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOGLYCEMIA	5.3% 2/38 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOKALEMIA	23.7% 9/38 • Number of events 21 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOMAGNESEMIA	15.8% 6/38 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPONATREMIA	18.4% 7/38 • Number of events 13 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	10.5% 4/38 • Number of events 15 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders HYPOTENSION	10.5% 4/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Endocrine disorders HYPOTHYROIDISM	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Immune system disorders IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	15.8% 6/38 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders INFUSION RELATED REACTION	7.9% 3/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY	5.3% 2/38 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations INR INCREASED	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders INSOMNIA	39.5% 15/38 • Number of events 16 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations INVESTIGATIONS - OTHER, SPECIFY	5.3% 2/38 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders IRON OVERLOAD	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders LEUKOCYTOSIS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders LOCALIZED EDEMA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations LUNG INFECTION	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations LYMPHOCYTE COUNT DECREASED	26.3% 10/38 • Number of events 26 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders MEMORY IMPAIRMENT	10.5% 4/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	28.9% 11/38 • Number of events 18 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations MUCOSAL INFECTION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders MUCOSITIS ORAL	26.3% 10/38 • Number of events 18 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS LOWER LIMB	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	13.2% 5/38 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders MYALGIA	10.5% 4/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders NAIL DISCOLORATION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders NAIL RIDGING	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders NAUSEA	78.9% 30/38 • Number of events 50 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders NECK PAIN	10.5% 4/38 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	10.5% 4/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations NEUTROPHIL COUNT DECREASED	31.6% 12/38 • Number of events 21 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders NON-CARDIAC CHEST PAIN	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders OBESITY	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ORAL DYSESTHESIA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ORAL PAIN	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders PALPITATIONS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders PARESTHESIA	7.9% 3/38 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders PERICARDIAL TAMPONADE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders PERIORBITAL EDEMA	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	76.3% 29/38 • Number of events 90 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders PHOTOPHOBIA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations PLATELET COUNT DECREASED	18.4% 7/38 • Number of events 21 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders POSTNASAL DRIP	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders PRESYNCOPE	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	2.6% 1/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders PRURITUS	7.9% 3/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders PSYCHIATRIC DISORDERS - OTHER, SPECIFY	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders RASH ACNEIFORM	5.3% 2/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders RENAL AND URINARY DISORDERS - OTHER, SPECIFY	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	15.8% 6/38 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders SINUS TACHYCARDIA	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	7.9% 3/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations SKIN INFECTION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders SLEEP APNEA	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders SORE THROAT	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders SPASTICITY	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders STOMACH PAIN	13.2% 5/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders SYNCOPE	10.5% 4/38 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders THROMBOEMBOLIC EVENT	18.4% 7/38 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders TINNITUS	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders TUMOR LYSIS SYNDROME	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOR PAIN	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations UPPER RESPIRATORY INFECTION	10.5% 4/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders URINARY FREQUENCY	5.3% 2/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders URINARY RETENTION	5.3% 2/38 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations URINARY TRACT INFECTION	5.3% 2/38 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders URINARY TRACT PAIN	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders URINARY URGENCY	7.9% 3/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders URTICARIA	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders VASCULAR DISORDERS - OTHER, SPECIFY	5.3% 2/38 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders VERTIGO	5.3% 2/38 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders VOMITING	42.1% 16/38 • Number of events 35 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations WEIGHT GAIN	13.2% 5/38 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations WEIGHT LOSS	52.6% 20/38 • Number of events 28 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders WHEEZING	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations WHITE BLOOD CELL DECREASED	23.7% 9/38 • Number of events 23 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations WOUND INFECTION	2.6% 1/38 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Additional Information

Clinical Data Analyst

Hoosier Cancer Research Network

Phone: 3179212050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place