Trial Outcomes & Findings for Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer (NCT NCT00003042)

NCT ID: NCT00003042

Last Updated: 2025-03-03

Results Overview

Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 41 participants
• Primary outcome timeframe: From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.
• Results posted on: 2025-03-03

Participant Flow

Participant milestones

Measure	Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin cyclophosphamide doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support conventional surgery peripheral blood stem cell transplantation	High-dose Chemo With Rescue Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support peripheral blood stem cell transplantation
Overall Study STARTED	14	27
Overall Study COMPLETED	14	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer

Baseline characteristics by cohort

Measure	Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue n=14 Participants Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin cyclophosphamide doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support conventional surgery peripheral blood stem cell transplantation	High-dose Chemo With Rescue n=27 Participants Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support peripheral blood stem cell transplantation	Total n=41 Participants Total of all reporting groups
Age, Continuous	49 years n=5 Participants	50 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	27 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	13 Participants n=5 Participants	25 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants	27 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.

Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment.

Outcome measures

Measure	Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue n=14 Participants Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin cyclophosphamide doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support conventional surgery peripheral blood stem cell transplantation	High-dose Chemo With Rescue n=27 Participants Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support peripheral blood stem cell transplantation
Three-year Relapse-free Survival	61.5 percentage of participants Interval 30.8 to 81.8	77.8 percentage of participants Interval 57.1 to 89.3

PRIMARY outcome

Timeframe: From date of mastectomy until date of death, 5 years post mastectomy.

Estimated using the product-limit method of Kaplan and Meier. Endpoint is defined as death due to any cause.

Outcome measures

Measure	Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue n=14 Participants Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin cyclophosphamide doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support conventional surgery peripheral blood stem cell transplantation	High-dose Chemo With Rescue n=27 Participants Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support peripheral blood stem cell transplantation
Five-year Overall Survival	69.2 percentage of participants Interval 37.3 to 87.2	70.4 percentage of participants Interval 49.4 to 83.9

Adverse Events

Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue

Serious events: 0 serious events

Other events: 13 other events

Deaths: 10 deaths

High-dose Chemo With Rescue

Serious events: 2 serious events

Other events: 23 other events

Deaths: 14 deaths

Serious adverse events

Measure	Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue n=14 participants at risk Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin cyclophosphamide doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support conventional surgery peripheral blood stem cell transplantation	High-dose Chemo With Rescue n=27 participants at risk Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support peripheral blood stem cell transplantation
Infections and infestations Skin infection	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Alkalosis	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue n=14 participants at risk Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin cyclophosphamide doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support conventional surgery peripheral blood stem cell transplantation	High-dose Chemo With Rescue n=27 participants at risk Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support peripheral blood stem cell transplantation
Vascular disorders Hypotension	50.0% 7/14 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.0% 17/27 • Number of events 24 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	14.3% 2/14 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 9 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	14.3% 2/14 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 9 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	7.1% 1/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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 discolouration	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	35.7% 5/14 • Number of events 9 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 6/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Flushing	21.4% 3/14 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hemorrhage	50.0% 7/14 • Number of events 26 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.1% 13/27 • Number of events 29 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	35.7% 5/14 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.0% 17/27 • Number of events 23 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Cerebellar	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 19 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Dysrhythmias	28.6% 4/14 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 9/27 • Number of events 15 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Fluid Retention	35.7% 5/14 • Number of events 24 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 26 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Haematemesis	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	42.9% 6/14 • Number of events 25 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.7% 11/27 • Number of events 27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Ischemia	28.6% 4/14 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 9/27 • Number of events 15 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericardial	28.6% 4/14 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 9/27 • Number of events 15 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	35.7% 5/14 • Number of events 24 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 26 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Stomatitis	35.7% 5/14 • Number of events 24 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 26 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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)	35.7% 5/14 • Number of events 16 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 9/27 • Number of events 9 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 12 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Febrile neutropenia	35.7% 5/14 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.7% 11/27 • Number of events 15 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Lymphatic disorder	7.1% 1/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Arrhythmia	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders EF/CHF	28.6% 4/14 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 9/27 • Number of events 15 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Left ventricular failure	21.4% 3/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.8% 4/27 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Myocardial ischemia	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericardial effusion	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	35.7% 5/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 13 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Ear disorder	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Hearing	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 16 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Hearing loss	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 19 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	14.3% 2/14 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.6% 8/27 • Number of events 9 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	35.7% 5/14 • Number of events 16 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 18/27 • Number of events 30 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	42.9% 6/14 • Number of events 18 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.1% 13/27 • Number of events 25 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea (Somlo COH)	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 10 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	7.1% 1/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia (Somlo COH)	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	7.1% 1/14 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Incontinence NOS	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Melaena	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	71.4% 10/14 • Number of events 26 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 18/27 • Number of events 34 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea (Somlo COH)	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 11 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Proctitis	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomatitis/phayngitis (Somlo COH)	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 10 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	71.4% 10/14 • Number of events 25 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	70.4% 19/27 • Number of events 35 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting (Somlo COH)	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 11 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	21.4% 3/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 9/27 • Number of events 9 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	57.1% 8/14 • Number of events 14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.6% 8/27 • Number of events 11 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	14.3% 2/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever (no infection)	28.6% 4/14 • Number of events 11 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 21 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.8% 4/27 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Irritability	7.1% 1/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Oedema NOS	35.7% 5/14 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.7% 11/27 • Number of events 14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.6% 8/27 • Number of events 12 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Hepatobiliary disorders Hepatobiliary disease	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Allergy	35.7% 5/14 • Number of events 24 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 26 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Hypersensitivity	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations AGC	35.7% 5/14 • Number of events 20 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 25 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	35.7% 5/14 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 15 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	7.1% 1/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alk Phos (Somlo COH)	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline Phosphatase	28.6% 4/14 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	14.3% 2/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Amylase	21.4% 3/14 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	21.4% 3/14 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin	28.6% 4/14 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin (Somlo COH)	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	21.4% 3/14 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.8% 4/27 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations HGB/HCT	28.6% 4/14 • Number of events 13 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.6% 8/27 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypercholesterolemia	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	42.9% 6/14 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.1% 13/27 • Number of events 17 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	21.4% 3/14 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophils (ANC) (Somlo COH)	21.4% 3/14 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.6% 8/27 • Number of events 14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations	50.0% 7/14 • Number of events 39 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 9/27 • Number of events 53 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Partial Thromboplastin Time	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 11 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	14.3% 2/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelets	35.7% 5/14 • Number of events 20 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 25 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelets (Somlo COH)	21.4% 3/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.6% 8/27 • Number of events 14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Prothrombin Time	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 12 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations SGOT (Somlo COH)	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations SGOT/SGT	28.6% 4/14 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations SGPT (Somlo COH)	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations WBC	28.6% 4/14 • Number of events 13 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.6% 8/27 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	21.4% 3/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	7.1% 1/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	28.6% 4/14 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 9/27 • Number of events 14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	28.6% 4/14 • Number of events 10 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 22 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	85.7% 12/14 • Number of events 24 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	85.2% 23/27 • Number of events 43 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	85.7% 12/14 • Number of events 22 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	81.5% 22/27 • Number of events 42 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	28.6% 4/14 • Number of events 10 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 22 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	71.4% 10/14 • Number of events 17 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	77.8% 21/27 • Number of events 37 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	7.1% 1/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	21.4% 3/14 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ataxia	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.7% 11/27 • Number of events 20 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Extrapyramidal disorder	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	71.4% 10/14 • Number of events 15 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.0% 17/27 • Number of events 29 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Motor Activity	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 19 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neuralgia	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neurological disorder NOS	14.3% 2/14 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 19 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	21.4% 3/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 9 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	42.9% 6/14 • Number of events 9 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	44.4% 12/27 • Number of events 19 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Speech disorder	7.1% 1/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 6/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Hallucination NOS	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Ideation	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 19 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	21.4% 3/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Mood	28.6% 4/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.0% 10/27 • Number of events 19 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Personality change	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/27 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Blood urine present	21.4% 3/14 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hematuria	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Proteinuria	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 3/27 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urine discoloration	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	21.4% 3/14 • Number of events 3 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.9% 7/27 • Number of events 8 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	28.6% 4/14 • Number of events 4 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 6/27 • Number of events 6 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	28.6% 4/14 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 6/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hiccough	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.4% 2/27 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	14.3% 2/14 • Number of events 2 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 6/27 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	42.9% 6/14 • Number of events 7 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.5% 5/27 • Number of events 5 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	7.1% 1/14 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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	42.9% 6/14 • Number of events 12 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 9/27 • Number of events 9 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/14 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.7% 1/27 • Number of events 1 • Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months). "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: pfrankel@coh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place