Trial Outcomes & Findings for Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma (NCT NCT01639131)

Last Updated: 2022-08-10

Results Overview

The Response Rate is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

9 months

Results posted on

2022-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine and Docetaxel Patients received intravenous gemcitabine 800mg/m2 on days 1 and 8 and docetaxel 70mg/m2 on day 8 of each 21 day cycle. Patients received filgrastim (G-CSF) on days 9 through 15 or pegfilgrastim 6mg on day 9 or 10 of each cycle. Gemcitabine: intravenous gemcitabine 800mg/m2 on days 1 and 8 Docetaxel: docetaxel 70mg/m2 on day 8 of each 21 day cycle Filgrastim or Pegfilgrastim: filgrastim (G-CSF) on days 9 through 15 or pegfilgrastim 6mg on day 9 or 10 of each cycle
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine and Docetaxel Patients received intravenous gemcitabine 800mg/m2 on days 1 and 8 and docetaxel 70mg/m2 on day 8 of each 21 day cycle. Patients received filgrastim (G-CSF) on days 9 through 15 or pegfilgrastim 6mg on day 9 or 10 of each cycle. Gemcitabine: intravenous gemcitabine 800mg/m2 on days 1 and 8 Docetaxel: docetaxel 70mg/m2 on day 8 of each 21 day cycle Filgrastim or Pegfilgrastim: filgrastim (G-CSF) on days 9 through 15 or pegfilgrastim 6mg on day 9 or 10 of each cycle
Overall Study Disease Progression	6

Baseline Characteristics

Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine and Docetaxel n=6 Participants Patients were treated with gemcitabine 800 mg/m2 on days 1 and 8 and docetaxel 70 mg/m2 on day 8 of each 21-day cycle. Patients received filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle. Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Outcome measures

Outcome measures
Measure	Gemcitabine and Docetaxel n=6 Participants Patients were treated with gemcitabine 800 mg/m2 on days 1 and 8 and docetaxel 70 mg/m2 on day 8 of each 21-day cycle. Patients received filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle. Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent. Gemcitabine: intravenous gemcitabine 800mg/m2 on days 1 and 8 Docetaxel: intravenous docetaxel 70mg/m2 on day 8 of each 21 day cycle Filgrastim or Pegfilgrastim: filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle
Response Rate	0 participants

SECONDARY outcome

Timeframe: 9 months

Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. PFS is defined as the number of months from the date of first dose of study drug to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Gemcitabine and Docetaxel n=6 Participants Patients were treated with gemcitabine 800 mg/m2 on days 1 and 8 and docetaxel 70 mg/m2 on day 8 of each 21-day cycle. Patients received filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle. Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent. Gemcitabine: intravenous gemcitabine 800mg/m2 on days 1 and 8 Docetaxel: intravenous docetaxel 70mg/m2 on day 8 of each 21 day cycle Filgrastim or Pegfilgrastim: filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle
Progression-free Survival (PFS)	1.79 months Interval 1.28 to The upper limit of the KM curve has not reached 50%, therefore there is no estimate for the upper confidence limit on the median

SECONDARY outcome

Timeframe: 62 months

Overall survival is the time from the start of first dose of study drug to death. OS will be measured from date of first dose of a study drug until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Gemcitabine and Docetaxel n=6 Participants Patients were treated with gemcitabine 800 mg/m2 on days 1 and 8 and docetaxel 70 mg/m2 on day 8 of each 21-day cycle. Patients received filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle. Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent. Gemcitabine: intravenous gemcitabine 800mg/m2 on days 1 and 8 Docetaxel: intravenous docetaxel 70mg/m2 on day 8 of each 21 day cycle Filgrastim or Pegfilgrastim: filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle
Overall Survival With Gemcitabine and Docetaxel Combination Therapy	15.67 months Interval 4.24 to The upper limit of the KM curve has not reached 50%, therefore there is no estimate for the upper confidence limit on the median

Adverse Events

Gemcitabine and Docetaxel

Serious events: 1 serious events

Other events: 6 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine and Docetaxel n=6 participants at risk Patients were treated with gemcitabine 800 mg/m2 on days 1 and 8 and docetaxel 70 mg/m2 on day 8 of each 21-day cycle. Patients received filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle. Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent.
Investigations fever	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations sepsis	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders neuropathic fever	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.

Other adverse events

Other adverse events
Measure	Gemcitabine and Docetaxel n=6 participants at risk Patients were treated with gemcitabine 800 mg/m2 on days 1 and 8 and docetaxel 70 mg/m2 on day 8 of each 21-day cycle. Patients received filgrastim (granulocyte colony-stimulating factor \[G-CSF\]) on days 9 through 15 or pegfilgrastim 6 mg on day 9 or 10 of each cycle. Patients were treated until disease progression or unacceptable adverse events (AEs), or withdrawn of the consent.
Investigations Lymphocyte count decreased	50.0% 3/6 • Number of events 14 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Anemia	50.0% 3/6 • Number of events 12 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Investigations White blood cell decreased	50.0% 3/6 • Number of events 6 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 1/6 • Number of events 6 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Investigations Neutrophil count decreased	16.7% 1/6 • Number of events 5 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Investigations Platelet count decreased	66.7% 4/6 • Number of events 5 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Metabolism and nutrition disorders Hypokalemia	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Metabolism and nutrition disorders Hypocalcemia	16.7% 1/6 • Number of events 5 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Investigations Alkaline Phosphatase increased	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Investigations Alanine Aminotransferase increased	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
General disorders Fever	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Skin and subcutaneous tissue disorders Alopecia	50.0% 3/6 • Number of events 4 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Metabolism and nutrition disorders Anorexia	16.7% 1/6 • Number of events 2 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 2/6 • Number of events 2 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
General disorders Fatigue	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Paresthesia	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Wheezing	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Investigations Weight Loss	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Vascular disorders Thrombus	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
General disorders Diarhhea	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Investigations Blood bilirubin increased	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Atelectasis	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Dysgeusia	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Renal and urinary disorders Hemoglobinuria	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Hypersomnia	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Cardiac disorders Pericardial effusion	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 4 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
General disorders Edema Face	16.7% 1/6 • Number of events 2 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
General disorders Edema limbs	33.3% 2/6 • Number of events 2 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Reproductive system and breast disorders Genital edema	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
General disorders Localized Edema	16.7% 1/6 • Number of events 1 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Mucositis oral	50.0% 3/6 • Number of events 5 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Peripheral Sensory Neuropathy	33.3% 2/6 • Number of events 2 • Survival was monitored for up to 62 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for 9 months. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of Serious and Other (Not Including Serious) Adverse Events.

Additional Information

Nilofer Azad, MD

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

Phone: 410-614-9169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place