Trial Outcomes & Findings for Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer (NCT NCT01523457)

Last Updated: 2017-08-30

Results Overview

The primary objective of this study is to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of FOLFIRINOX. Tumour response was determined according to RECIST 1.1 by independent radiology review.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

24 weeks

Results posted on

2017-08-30

Participant Flow

Patients with pathologically confirmed, measurable or non-measurable assessable MPC or LAPC (including unresectable and borderline resectable) were recruited from November 2011 through January 2014.

Participant milestones

Participant milestones
Measure	MPC Modified FOLFIRINOX Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	LAPC Modified FOLFIRINOX Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Overall Study STARTED	44	31
Overall Study COMPLETED	37	29
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MPC Modified FOLFIRINOX Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	LAPC Modified FOLFIRINOX Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Overall Study Withdrawal by Subject	7	2

Baseline Characteristics

Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MPC Modified FOLFIRINOX n=37 Participants Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	LAPC Modified FOLFIRINOX n=31 Participants Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	Total n=68 Participants Total of all reporting groups
Age, Customized Age	62 years n=99 Participants	63 years n=107 Participants	62 years n=206 Participants
Sex: Female, Male Female	16 Participants n=99 Participants	11 Participants n=107 Participants	27 Participants n=206 Participants
Sex: Female, Male Male	21 Participants n=99 Participants	20 Participants n=107 Participants	41 Participants n=206 Participants
ECOG Performance Status 0: Fully active	17 participants n=99 Participants	15 participants n=107 Participants	32 participants n=206 Participants
ECOG Performance Status 1: Restricted in physically strenuous activity	20 participants n=99 Participants	16 participants n=107 Participants	36 participants n=206 Participants
Pancreatic tumour location Head	17 participants n=99 Participants	27 participants n=107 Participants	44 participants n=206 Participants
Pancreatic tumour location Body	14 participants n=99 Participants	4 participants n=107 Participants	18 participants n=206 Participants
Pancreatic tumour location Tumour Resection	6 participants n=99 Participants	0 participants n=107 Participants	6 participants n=206 Participants
Level of CA19.9 Normal	4 participants n=99 Participants	3 participants n=107 Participants	7 participants n=206 Participants
Level of CA19.9 Elevated, <59 Upper Limits of Normal	18 participants n=99 Participants	24 participants n=107 Participants	42 participants n=206 Participants
Level of CA19.9 Elevated, >=59 Upper Limits of Normal	15 participants n=99 Participants	4 participants n=107 Participants	19 participants n=206 Participants
Biliary stent Yes	9 participants n=99 Participants	17 participants n=107 Participants	26 participants n=206 Participants
Biliary stent No	28 participants n=99 Participants	14 participants n=107 Participants	42 participants n=206 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).

Outcome measures

Outcome measures
Measure	MPC Modified FOLFIRINOX n=37 Participants Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	LAPC Modified FOLFIRINOX n=29 Participants Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Progression Free Survival	54 percentage of participants	97 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1 by independent radiology review) at 8 week intervals in patients with metastatic disease and in patients with locally advanced disease.

Outcome measures

Outcome measures
Measure	MPC Modified FOLFIRINOX n=37 Participants Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	LAPC Modified FOLFIRINOX n=29 Participants Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Objective Response Rate	35.1 percentage of participants	17.2 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Overall survival will be determined in patients with metastatic disease and in patients with locally advanced disease.

Outcome measures

Outcome measures
Measure	MPC Modified FOLFIRINOX n=37 Participants Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	LAPC Modified FOLFIRINOX n=29 Participants Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Overall Survival	81 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Population: One of the total 75 patients did not receive treatment and was excluded from toxicity analysis. Treatment-related grade 3 and 4 adverse events observed in our study and in the historical control group treated with standard FOLFIRINOX.

Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0. Rates of grade 3 and 4 toxicities will be compared to historical controls. MPC and LAPC are combined because they were given the exact same medication. The study aimed to compare this dosage with historical dosage, so this comparison is the most appropriate.

Outcome measures

Outcome measures
Measure	MPC Modified FOLFIRINOX n=43 Participants Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	LAPC Modified FOLFIRINOX n=31 Participants Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Toxicity Neutropenia	4 participants	5 participants
Toxicity Thrombocytopenia	5 participants	2 participants
Toxicity Anaemia	2 participants	2 participants
Toxicity Febrile neutropenia	1 participants	2 participants
Toxicity Diarrhea	8 participants	4 participants
Toxicity Fatigue	5 participants	4 participants
Toxicity Alanine aminotransferase (ALT) increased	3 participants	0 participants
Toxicity Thromboembolic event	3 participants	0 participants
Toxicity Peripheral sensory neuropathy	2 participants	0 participants
Toxicity Vomiting	1 participants	1 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Only LAPC patients were considered in the analysis. 13 patients in the LAPC group had surgical resection. The definition of locally unresectable and borderline were clarified in the protocol.

The rate of surgical resection in the cohort of patients with locally advanced disease will be determined.

Outcome measures

Outcome measures
Measure	MPC Modified FOLFIRINOX Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	LAPC Modified FOLFIRINOX n=31 Participants Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Rate of Resection in Patients With Locally Advanced Disease Total	—	13 participants
Rate of Resection in Patients With Locally Advanced Disease Unresectable	—	6 participants
Rate of Resection in Patients With Locally Advanced Disease Borderline	—	7 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: This outcome was included in the 2012 protocol registration and actually describes a series of analyses that were not fully conducted, and will not be. The outcome measures described in the outcome description are presented as separated outcome measures elsewhere in this results record.

The time to progression, objective response rate, and overall survival will be correlated with early changes in glucose metabolism using FDG-positron emission tomography (PET) scanning in patients with metastatic disease and locally advanced disease.

Outcome measures

Outcome data not reported

Adverse Events

MPC Modified FOLFIRINOX

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

LAPC Modified FOLFIRINOX

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MPC Modified FOLFIRINOX n=43 participants at risk；n=44 participants at risk Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.	LAPC Modified FOLFIRINOX n=31 participants at risk Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Blood and lymphatic system disorders Neutropenia	9.3% 4/43 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).	16.1% 5/31 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).
Blood and lymphatic system disorders Thrombocytopenia	11.6% 5/43 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).	6.5% 2/31 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).
Blood and lymphatic system disorders Anaemia	4.7% 2/43 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).	6.5% 2/31 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).
Blood and lymphatic system disorders Febrile Neurotropenia	2.3% 1/43 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).	6.5% 2/31 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).
Gastrointestinal disorders Diarrhea	18.6% 8/43 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).	12.9% 4/31 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).
General disorders Fatigue	11.6% 5/43 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).	12.9% 4/31 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).
General disorders Alanine aminotransferase	7.0% 3/43 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).	0.00% 0/31 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).
Blood and lymphatic system disorders Thromboembolic Event	7.0% 3/43 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).	0.00% 0/31 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).
Nervous system disorders Peripheral sensory neuropathy	4.7% 2/43 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).	0.00% 0/31 • Adverse events are reported over the total duration of the study by treatment arm. Reported below are grade 3 and 4 adverse events reported at greater than 5% per treatment arm collected. Serious Adverse Events and All Cause Mortality are reported for the overall population, while the Adverse Events are reported only for those where toxicity was assessed (1 less participant overall, see Outcome Measures).

Additional Information

Jill Lacy

Yale University

Phone: +1 (203) 737-1600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place