Trial Outcomes & Findings for Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction (NCT NCT00540982)

Last Updated: 2025-07-02

Results Overview

Pharmacokinetics were evaluated in patients with sufficient dosing information and plasma concentration versus time data over 0-24 hours following vinorelbine infusion to allow calculation of area-under-the-curve from zero to 24 hours after infusion (AUC0-24). Furthermore, dose-normalization of AUC0-24 to the standard 30 mg/m2 dose was performed to allow evaluation of the relationship between liver function and AUC of vinorelbine. Data were collected at 0 and 24 hours post-dose.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

47 participants

Primary outcome timeframe

2 months post treatment

Results posted on

2025-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients All patients with treatment-refractory solid tumors enrolled on the study.
Overall Study STARTED	47
Overall Study Normal Liver Function	11
Overall Study Mild Liver Dysfunction	6
Overall Study Moderate Liver Dysfunction	18
Overall Study Severe Liver Dysfunction	12
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=47 Participants All patients with treatment-refractory solid tumors enrolled on the study.
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	23 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months post treatment

Population: Vinorelbine plasma AUC0-24 data were available for a total of 30 subjects.

Outcome measures

Outcome measures
Measure	Normal n=10 Participants Patients were administered weekly 30mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum). Normal liver function was defined as bilirubin \<1.5 mg/dL	Mild n=4 Participants Patients were administered weekly 30mg/m2, 20mg/m2 or 15mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum). Mild liver dysfunction defined as bilirubin \<1.5 mg/dL and ≥1 of the following: AST/ALT 1.5-2.5 X ULN or ALK 1.5-3 X ULN	Moderate n=12 Participants Patients were administered weekly 30mg/m2 or 15mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum). Moderate liver dysfunction was defined as bilirubin 1.5-3.0 mg/dL and/or ≥1 of the following: AST/ALT \>2.5 X ULN or ALK \>3 X ULN.	Severe n=4 Participants Patients were administered weekly 20mg/m2 or 7.5mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum). Severe liver dysfunction was defined as bilirubin \>3.0 mg/dL.	Moderate (30mg/m2) Moderate Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.	Moderate (15mg/m2) Moderate Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.	Severe (20mg/m2) Severe Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.	Severe (7.5mg/m2) Severe Liver Dysfunction Group with 7.5 mg/m2 of Vinorelbine.
Area Under the Curve	271 ng/ml x hr Interval 111.0 to 593.0	537 ng/ml x hr Interval 366.0 to 812.0	341 ng/ml x hr Interval 251.0 to 1318.0	324 ng/ml x hr Interval 167.0 to 1090.0	—	—	—	—

PRIMARY outcome

Timeframe: 3 weeks after the stop of treatment

Grade 3 \& 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 2.0.

Outcome measures

Outcome measures
Measure	Normal n=11 Participants Patients were administered weekly 30mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum). Normal liver function was defined as bilirubin \<1.5 mg/dL	Mild n=1 Participants Patients were administered weekly 30mg/m2, 20mg/m2 or 15mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum). Mild liver dysfunction defined as bilirubin \<1.5 mg/dL and ≥1 of the following: AST/ALT 1.5-2.5 X ULN or ALK 1.5-3 X ULN	Moderate n=3 Participants Patients were administered weekly 30mg/m2 or 15mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum). Moderate liver dysfunction was defined as bilirubin 1.5-3.0 mg/dL and/or ≥1 of the following: AST/ALT \>2.5 X ULN or ALK \>3 X ULN.	Severe n=2 Participants Patients were administered weekly 20mg/m2 or 7.5mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum). Severe liver dysfunction was defined as bilirubin \>3.0 mg/dL.	Moderate (30mg/m2) n=8 Participants Moderate Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.	Moderate (15mg/m2) n=10 Participants Moderate Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.	Severe (20mg/m2) n=7 Participants Severe Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.	Severe (7.5mg/m2) n=5 Participants Severe Liver Dysfunction Group with 7.5 mg/m2 of Vinorelbine.
Number of Participants With Grade 3 and 4 Toxicities Hypotension	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade 3 and 4 Toxicities Hypertension	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Anemia	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Lymphopenia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Neutropenia	4 Participants	1 Participants	2 Participants	1 Participants	7 Participants	4 Participants	4 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Thrombocytopenia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Anorexia/weight loss	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Ascites	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Cerebrovascular ischemia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Confusion	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade 3 and 4 Toxicities Constipation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 and 4 Toxicities Dehydration	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Diarrhea	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Dyspnea	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Edema	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Fatigue	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade 3 and 4 Toxicities Generalized weakness	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Hallucinations	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Infection (including febrile neutropenia)	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Thromboembolism	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Abnormal LFTs	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With Grade 3 and 4 Toxicities Hypercalcemia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Hyperglycemia	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Grade 3 and 4 Toxicities Hyperkalemia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Hypophosphatemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Neuropathy	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Pain	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Petechiae/purpura	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Pulmonary hemorrhage	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Elevated INR	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Hypokalemia	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 and 4 Toxicities Hyponatremia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

Adverse Events

Normal (30mg/m2)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 11 deaths

Mild (30mg/m2)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Mild (20mg/m2)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Mild (15mg/m2)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Moderate (30mg/m2)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 8 deaths

Moderate (15mg/m2)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 10 deaths

Severe (20mg/m2)

Serious events: 4 serious events

Other events: 7 other events

Deaths: 7 deaths

Severe (7.5mg/m2)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Normal (30mg/m2) n=11 participants at risk Normal Liver Function Group with 30 mg/m2 of Vinorelbine.	Mild (30mg/m2) n=1 participants at risk Mild Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.	Mild (20mg/m2) n=3 participants at risk Mild Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.	Mild (15mg/m2) n=2 participants at risk Mild Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.	Moderate (30mg/m2) n=8 participants at risk Moderate Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.	Moderate (15mg/m2) n=10 participants at risk Moderate Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.	Severe (20mg/m2) n=7 participants at risk Severe Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.	Severe (7.5mg/m2) n=5 participants at risk Severe Liver Dysfunction Group with 7.5 mg/m2 of Vinorelbine.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection NOS	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection, Bacterial (COH)	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Other adverse events
Measure	Normal (30mg/m2) n=11 participants at risk Normal Liver Function Group with 30 mg/m2 of Vinorelbine.	Mild (30mg/m2) n=1 participants at risk Mild Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.	Mild (20mg/m2) n=3 participants at risk Mild Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.	Mild (15mg/m2) n=2 participants at risk Mild Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.	Moderate (30mg/m2) n=8 participants at risk Moderate Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.	Moderate (15mg/m2) n=10 participants at risk Moderate Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.	Severe (20mg/m2) n=7 participants at risk Severe Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.	Severe (7.5mg/m2) n=5 participants at risk Severe Liver Dysfunction Group with 7.5 mg/m2 of Vinorelbine.
Cardiac disorders Ischemia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Other Misc	36.4% 4/11 • Number of events 35 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.0% 3/10 • Number of events 19 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 39 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum magnesium decreased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericardial	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Cerebellar	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Clinical (Physical Exam)	36.4% 4/11 • Number of events 15 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 12 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 32 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Dysrhythmias	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fluid Retention	45.5% 5/11 • Number of events 25 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Haematemesis	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Hemorrhage	45.5% 5/11 • Number of events 25 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	45.5% 5/11 • Number of events 25 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 6/10 • Number of events 13 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary	45.5% 5/11 • Number of events 25 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Stomatitis	45.5% 5/11 • Number of events 25 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Weight (Food Intake)	45.5% 5/11 • Number of events 25 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Clinical Coagulation	18.2% 2/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Hemoglobin decreased	54.5% 6/11 • Number of events 12 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 33 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	62.5% 5/8 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 6/10 • Number of events 44 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 7/7 • Number of events 9 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Lymphatics	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Packed red blood cell transfusion	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Transfusion: pRBCs	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders EF/CHF	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Ventricular arrhythmia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Hearing	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye disorder	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ascites	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	54.5% 6/11 • Number of events 19 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 4/8 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 5/10 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	80.0% 4/5 • Number of events 17 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	45.5% 5/11 • Number of events 19 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	80.0% 4/5 • Number of events 14 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	54.5% 6/11 • Number of events 19 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	62.5% 5/8 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 5/10 • Number of events 10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	80.0% 4/5 • Number of events 16 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	54.5% 6/11 • Number of events 19 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.5% 3/8 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	80.0% 4/5 • Number of events 16 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	72.7% 8/11 • Number of events 17 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 13 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 2/2 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 6/8 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	90.0% 9/10 • Number of events 14 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	85.7% 6/7 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 5/5 • Number of events 24 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever (no infection)	36.4% 4/11 • Number of events 10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 20 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Oedema NOS	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 12 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 5/10 • Number of events 12 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	36.4% 4/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 9 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 4/8 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.0% 3/10 • Number of events 10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Hepatobiliary disorders Hepatobiliary disease	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Allergy	45.5% 5/11 • Number of events 25 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection NOS	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection without neutropenia	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.5% 3/8 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Bruising	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations AGC	45.5% 5/11 • Number of events 21 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 13 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 29 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	27.3% 3/11 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	62.5% 5/8 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 5/10 • Number of events 20 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	85.7% 6/7 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 9 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline Phosphatase	36.4% 4/11 • Number of events 15 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 12 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 32 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	36.4% 4/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 33 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 6/8 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 6/10 • Number of events 44 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	71.4% 5/7 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Amylase	27.3% 3/11 • Number of events 9 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 19 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	27.3% 3/11 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 33 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 6/8 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 6/10 • Number of events 33 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	85.7% 6/7 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin	36.4% 4/11 • Number of events 15 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 12 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 32 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin increased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	71.4% 5/7 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine	18.2% 2/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.5% 3/8 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Fibrinogen	18.2% 2/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations HGB/HCT	45.5% 5/11 • Number of events 23 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 13 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 29 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypercholesterolemia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.0% 3/10 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	18.2% 2/11 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 4/8 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	27.3% 3/11 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 16 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	45.5% 5/11 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 6/8 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	71.4% 5/7 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Partial Thromboplastin Time	18.2% 2/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelets	45.5% 5/11 • Number of events 23 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 13 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 29 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Prothrombin Time	18.2% 2/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations SGOT/SGT	36.4% 4/11 • Number of events 15 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 12 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 32 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Serum cholesterol increased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations WBC	45.5% 5/11 • Number of events 23 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 13 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 29 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	54.5% 6/11 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 24 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	62.5% 5/8 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood bicarbonate decreased	9.1% 1/11 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood glucose increased	18.2% 2/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	62.5% 5/8 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood uric acid increased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.5% 3/8 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	27.3% 3/11 • Number of events 9 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 13 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 19 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	45.5% 5/11 • Number of events 14 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 25 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 2/2 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	70.0% 7/10 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	80.0% 4/5 • Number of events 24 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypermagnesemia	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperuricemia	9.1% 1/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 13 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	18.2% 2/11 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 6/10 • Number of events 39 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	45.5% 5/11 • Number of events 12 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 2/2 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 5/10 • Number of events 17 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 5/5 • Number of events 23 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	27.3% 3/11 • Number of events 9 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.0% 3/10 • Number of events 9 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 19 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	27.3% 3/11 • Number of events 9 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.0% 3/10 • Number of events 8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 19 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum albumin decreased	27.3% 3/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 4/8 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	71.4% 5/7 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.5% 3/8 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium increased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum glucose decreased	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum phosphate decreased	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.5% 3/8 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 4/8 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium decreased	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 4/8 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint pain	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Cortical/State of Consciousness	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Depressed level of consciousness	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.5% 3/8 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	27.3% 3/11 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ischemia cerebrovascular	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Motor Activity	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral Nervous System Sensory	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	27.3% 3/11 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	9.1% 1/11 • Number of events 6 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.0% 3/10 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Speech disorder	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Tremor	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.5% 3/8 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Hallucinations	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Ideation	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.0% 3/10 • Number of events 10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Mood	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Personality change	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Bladder pain	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hematuria	18.2% 2/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hematuria (in the absence of vaginal bleeding)	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Protein urine positive	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Proteinuria	18.2% 2/11 • Number of events 7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary retention	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.0% 3/10 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 2/11 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 4/10 • Number of events 9 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 4 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 1/1 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	63.6% 7/11 • Number of events 27 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 1/2 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 5/10 • Number of events 14 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 3/5 • Number of events 22 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Extensive Skin Rash	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Local Skin Rash	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/10 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Sweating	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 1/8 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	9.1% 1/11 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 2/8 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 1/5 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	18.2% 2/11 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.0% 1/10 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 2/5 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombosis	0.00% 0/11 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/1 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/8 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 2/10 • Number of events 2 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/5 • Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place