Trial Outcomes & Findings for Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer (NCT NCT01280643)

NCT ID: NCT01280643

Last Updated: 2021-03-15

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

Over 21 months

Results posted on

2021-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Arm B Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm C Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm D Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies
Overall Study STARTED	1	1	1
Overall Study COMPLETED	0	1	1
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm B n=1 Participants Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm C n=1 Participants Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm D n=1 Participants Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm E Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. irinotecan hydrochloride: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm F Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. oxaliplatin: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	ARM G Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. irinotecan hydrochloride: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm H Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. oxaliplatin: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm I Patients receive treatment as in Arm D. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	—	—	—	—	—	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	—	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	—	—	—	—	—	2 Participants n=42 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	—	—	—	—	—	1 Participants n=42 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	—	—	—	—	—	0 Participants n=42 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	—	—	—	—	—	3 Participants n=42 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	—	—	—	—	—	3 participants n=42 Participants

PRIMARY outcome

Timeframe: Over 21 months

Population: Too few enrolled participants for meaningful analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Over 21 months

Population: Too few enrolled participants for meaningful analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Over 21 months

Population: Too few enrolled participants for meaningful analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Over 21 months

Population: Too few enrolled participants for meaningful analysis

Outcome measures

Outcome data not reported

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm C

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Arm D

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm E

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm F

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ARM G

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm H

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm B n=1 participants at risk Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm C n=1 participants at risk Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm D n=1 participants at risk Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm E Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. irinotecan hydrochloride: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm F Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. oxaliplatin: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	ARM G Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. irinotecan hydrochloride: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm H Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. oxaliplatin: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm I Patients receive treatment as in Arm D. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies
Cardiac disorders Hospitalization - Chest pain	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual

Other adverse events

Other adverse events
Measure	Arm A Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm B n=1 participants at risk Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm C n=1 participants at risk Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm D n=1 participants at risk Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm E Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. irinotecan hydrochloride: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm F Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. oxaliplatin: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	ARM G Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. irinotecan hydrochloride: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm H Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. oxaliplatin: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies	Arm I Patients receive treatment as in Arm D. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies
General disorders Fatigue	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
General disorders Fever	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 4 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Diarrhea/Constipation	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Nausea	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Vomiting	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 3 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Epistaxis	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Dysguesia	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Hemorrhoids	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
General disorders Sour stomach	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 3 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Hematochezia	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Respiratory, thoracic and mediastinal disorders Dyspnea	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Cardiac disorders Edema	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Respiratory, thoracic and mediastinal disorders Cough	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Nervous system disorders Sensory neuropathy	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 2 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Nervous system disorders Parasthesias	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Nervous system disorders Pain	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Dyspepsia	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Nervous system disorders Restless legs	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Psychiatric disorders Anxiety	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Musculoskeletal and connective tissue disorders Muscle cramps	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Skin and subcutaneous tissue disorders Alopecia	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
General disorders Flushed face	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Anorexia	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Pain	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Gastrointestinal disorders Pharyngitis	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Nervous system disorders Insomnia	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Nervous system disorders Twitching/restlessness	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Musculoskeletal and connective tissue disorders Myalgia	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
Skin and subcutaneous tissue disorders Eczema	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	100.0% 1/1 • Number of events 1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	0.00% 0/1 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual	— 0/0 No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual

Additional Information

Dr. Crystal Denlinger

Fox Chase Cancer Center

Phone: 215-214-1676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place