Trial Outcomes & Findings for A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1) (NCT NCT02905578)

NCT ID: NCT02905578

Last Updated: 2026-07-23

Results Overview

Time, measured in months, from the start of chemotherapy (C1D1) to death from any cause or until trial completion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Every 2 months until death from any cause, up to approximately 69 months.

Results posted on

2026-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Ascorbate Group Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks	Control Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Each cycle has 1 rest week
Overall Study STARTED	19	18
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ascorbate Group n=18 Participants Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks	Control n=16 Participants Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Each cycle has 1 rest week	Total n=34 Participants Total of all reporting groups
Age, Continuous	58.5 year n=9 Participants	65 year n=27 Participants	60.5 year n=267 Participants
Sex: Female, Male Female	6 Participants n=9 Participants	8 Participants n=27 Participants	14 Participants n=267 Participants
Sex: Female, Male Male	12 Participants n=9 Participants	8 Participants n=27 Participants	20 Participants n=267 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) White	17 Participants n=9 Participants	15 Participants n=27 Participants	32 Participants n=267 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	1 Participants n=27 Participants	2 Participants n=267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=9 Participants	16 Participants n=27 Participants	34 Participants n=267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Region of Enrollment United States	18 Participants n=9 Participants	16 Participants n=27 Participants	34 Participants n=267 Participants
ECOG Performance status (PS) PS 0: Fully active, no restrictions	5 Participants n=9 Participants	8 Participants n=27 Participants	13 Participants n=267 Participants
ECOG Performance status (PS) PS 1: Restricted in physically strenuous activity	11 Participants n=9 Participants	6 Participants n=27 Participants	17 Participants n=267 Participants
ECOG Performance status (PS) PS 2: Ambulatory and capable of all selfcare but unable to carry out any work activities	2 Participants n=9 Participants	2 Participants n=27 Participants	4 Participants n=267 Participants

PRIMARY outcome

Timeframe: Every 2 months until death from any cause, up to approximately 69 months.

Time, measured in months, from the start of chemotherapy (C1D1) to death from any cause or until trial completion.

Outcome measures

Outcome measures
Measure	Ascorbate Group n=18 Participants Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks	Control n=16 Participants Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Each cycle has 1 rest week
Overall Survival	16 months Interval 8.6 to One-sided stratified log-rank test; Upper confidence interval not achieved due to an insufficient number of participants with events.	8.3 months Interval 5.6 to One-sided stratified log-rank test; Upper confidence interval not achieved due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: Every 2 months to date of progression, up to approximately 69 months.

Time, measured in months, it takes disease to progress, where disease progression is defined by the RECIST criteria (v1.1). Timeframe is from treatment day 1 to date of disease progression or until trial closure.

Outcome measures

Outcome measures
Measure	Ascorbate Group n=18 Participants Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks	Control n=16 Participants Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Each cycle has 1 rest week
Progression Free Survival	6.2 Months Interval 3.9 to One-sided stratified log-rank test; Upper confidence interval not achieved due to an insufficient number of participants with events.	3.9 Months Interval 2.3 to One-sided stratified log-rank test; Upper confidence interval not achieved due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: Every 2 months for up to 10 years

Determine the objective response rate of the disease, assessed every 2 months using CT or MRI, and evaluated/defined using the RECIST criteria (v1.1). Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 10 serious events

Other events: 16 other events

Deaths: 16 deaths

Ascorbate Group

Serious events: 10 serious events

Other events: 18 other events

Deaths: 18 deaths

Serious adverse events

Other adverse events

Additional Information

Joseph J. Cullen, MD, FACS

The University of Iowa

Phone: 319-356-1616

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control n=16 participants at risk Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Each cycle has 1 rest week	Ascorbate Group n=18 participants at risk Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks
Investigations Fever	12.5% 2/16 • Number of events 5 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	16.7% 3/18 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Cholangitis	6.2% 1/16 • Number of events 2 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	16.7% 3/18 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Sepsis	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	16.7% 3/18 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Cardiac disorders Atrial Fibrillation	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	11.1% 2/18 • Number of events 2 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Clostridium Difficile Enteritis	12.5% 2/16 • Number of events 2 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Investigations Death, not otherwise specified	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	11.1% 2/18 • Number of events 2 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Febrile Neutropenia	12.5% 2/16 • Number of events 2 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Pneumonia	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Small Intestinal Obstruction	6.2% 1/16 • Number of events 2 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Vascular disorders Thrombosis	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Vomiting	12.5% 2/16 • Number of events 2 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Abdominal Pain	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Bile duct stenosis	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders biliary obstruction	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Cardiac disorders Cardiac arrest	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Cather infection	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Colonic hemorrhage	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Diverticulitis, perforated	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Endocarditis infective	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Gastric obstruction	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Metabolism and nutrition disorders Hyperkalemia	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Vascular disorders Hypovolemic shock	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders inguinal hernia	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Lung infection	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Nausea	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Investigations platelet count decreased	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Cardiac disorders Prolonged QTc	6.2% 1/16 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Vascular disorders pulmonary embolism	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Vascular disorders Transient ischemic attack	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 1 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)

Measure	Control n=16 participants at risk Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Each cycle has 1 rest week	Ascorbate Group n=18 participants at risk Each cycle is 4 calendar weeks Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks
Gastrointestinal disorders Nausea, grade 3	12.5% 2/16 • Number of events 6 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Vomiting, grade 3	12.5% 2/16 • Number of events 6 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
General disorders Fatigue, grade 3	6.2% 1/16 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	16.7% 3/18 • Number of events 12 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Infection, grade 3	68.8% 11/16 • Number of events 11 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	33.3% 6/18 • Number of events 6 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Infections and infestations Infection, grade 4	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	11.1% 2/18 • Number of events 2 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Investigations Hypertension, grade 3	6.2% 1/16 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Investigations Neutrophil count decreased, grade 3	31.2% 5/16 • Number of events 54 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	22.2% 4/18 • Number of events 48 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Investigations Neutrophil count decreased, grade 4	31.2% 5/16 • Number of events 20 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	11.1% 2/18 • Number of events 20 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Blood and lymphatic system disorders Febrile neutropenia	12.5% 2/16 • Number of events 6 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Constipation	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	11.1% 2/18 • Number of events 6 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Gastrointestinal disorders Diarrhea, grade 3	12.5% 2/16 • Number of events 6 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	11.1% 2/18 • Number of events 15 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Investigations Pain	18.8% 3/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	11.1% 2/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Investigations Platelet count decreased, grade 3	6.2% 1/16 • Number of events 12 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Investigations Platelet count decreased, grade 4	12.5% 2/16 • Number of events 8 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Investigations Weight loss, grade 3	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Metabolism and nutrition disorders Anorexia	6.2% 1/16 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	0.00% 0/18 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)
Nervous system disorders Peripheral sensory neuropathy, grade 3	0.00% 0/16 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)	5.6% 1/18 • Number of events 3 • Monthly through 30 days after end of treatment, up to approx. 69 months Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v4)