Trial Outcomes & Findings for An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer (NCT NCT03077698)

Last Updated: 2022-06-07

Results Overview

Subjects in the Full Analysis Set (FAS) population will be assessed for ODC. The FAS population includes those subjects all treated in TP2 who either undergo a CT or MRI scan with tumor assessment at 12 weeks (i.e. they have not discontinued treatment prior to 12 weeks) or those who have discontinued TP2 prior to 12 weeks solely due to documented disease progression. Radiographic disease progression and responses will be defined using RECIST 1.1 criteria: Control Response(CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions. The appearance of new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

During TP2 Every 12 weeks, until disease progression up to 24 months

Results posted on

2022-06-07

Participant Flow

Subjects with PrR (+) tumors began in Treatment Period 1 receiving only Progestin Monotherapy. If PrR (+) subjects had disease progression they continued into Treatment Period 2 receiving Progestin and Sodium Cridanimod therapy. Subjects with PrR (-) tumors enrolled directly into Treatment Period 2.

Participant milestones

Participant milestones
Measure	PrR (+) Subjects Subjects noted at Screening to have PrR (+) tumors were enrolled into Treatment Period 1 (TP1) receiving Progestin Monotherapy. Subjects noted to have Progressive Disease rolled into Treatment Period 2 (TP2) and received combination therapy of Sodium Cridanimod and Progestin. PrR (+) subjects that had Disease Control or Stable Disease after 24 weeks of Monotherapy treatment were not eligible to participate in TP2 and were discontinued.	PrR (-) Subjects Subjects with PrR(-) tumors at screening will be enrolled directly into Treatment Period 2 (TP2) receiving combination therapy of Sodium Cridanimod and Progestin.
Progestin Monotherapy STARTED	16	0
Progestin Monotherapy COMPLETED	6	0
Progestin Monotherapy NOT COMPLETED	10	0
Sodium Cridanimod & Progestin Therapy STARTED	6	9
Sodium Cridanimod & Progestin Therapy COMPLETED	0	0
Sodium Cridanimod & Progestin Therapy NOT COMPLETED	6	9
Safety Follow Up STARTED	6	9
Safety Follow Up COMPLETED	3	8
Safety Follow Up NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PrR (+) Subjects Subjects noted at Screening to have PrR (+) tumors were enrolled into Treatment Period 1 (TP1) receiving Progestin Monotherapy. Subjects noted to have Progressive Disease rolled into Treatment Period 2 (TP2) and received combination therapy of Sodium Cridanimod and Progestin. PrR (+) subjects that had Disease Control or Stable Disease after 24 weeks of Monotherapy treatment were not eligible to participate in TP2 and were discontinued.	PrR (-) Subjects Subjects with PrR(-) tumors at screening will be enrolled directly into Treatment Period 2 (TP2) receiving combination therapy of Sodium Cridanimod and Progestin.
Progestin Monotherapy Stable Disease	8	0
Progestin Monotherapy Adverse Event	1	0
Progestin Monotherapy Death	1	0
Sodium Cridanimod & Progestin Therapy Withdrawal by Subject	0	2
Sodium Cridanimod & Progestin Therapy Disease Progression	6	5
Sodium Cridanimod & Progestin Therapy Adverse Event	0	2
Safety Follow Up Withdrawal by Subject	2	1
Safety Follow Up Transfer of care to hospice	1	0

Baseline Characteristics

An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PrR (+) Subjects n=16 Participants Subjects noted at Screening to have PrR (+) tumors were enrolled into Treatment Period 1 (TP1) receiving Progestin Monotherapy. Subjects noted to have Progressive Disease rolled into Treatment Period 2 (TP2) and received combination therapy of Sodium Cridanimod and Progestin. PrR (+) subjects that had Disease Control or Stable Disease after 24 weeks of Monotherapy treatment were not eligible to participate in TP2 and were discontinued.	PrR(-) Subjects n=9 Participants Subjects with PrR(-) tumors at screening will be enrolled directly into Treatment Period 2 (TP2) receiving combination therapy of Sodium Cridanimod and Progestin.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	9 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: During TP2 Every 12 weeks, until disease progression up to 24 months

Population: A total of 15 subjects entered Treatment Period 2, which included the 9 subjects who were PrR negative and the 6 subjects who were PrR positive and completed Treatment Period 1, and received treatment with Intramuscular (IM) sodium cridanimod in combination with oral progestin (megestrol acetate). 2 subjects were unevaluable and withdrew prior to meeting criteria for inclusion in FAS population.

Outcome measures

Outcome measures
Measure	Sodium Cridanimod & Progestin Therapy n=13 Participants Sodium Cridanimod and progestin therapy (megestrol acetate) combination Sodium Cridanimod: The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative. progestin therapy: The study will investigate the use of progestin therapy in conjunction with Sodium Cridanimod
Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements Progressive Disease	8 Participants
Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements Stable Disease	5 Participants
Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements Partial Response	0 Participants
Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements Control Response	0 Participants

SECONDARY outcome

Timeframe: 24 months

Population: A total of 15 subjects entered Treatment Period 2, which included the 9 subjects who were PrR negative and the 6 subjects who were PrR positive and completed Treatment Period 1, and received treatment with IM sodium cridanimod in combination with oral progestin (megestrol acetate). Four (4) subjects withdrew from the study prior to meeting evaluable criteria for ORR

The best overall response was the best response recorded from the start of Treatment Period 2 until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).To be assigned a status of CR or PR, tumor measurements were confirmed by repeat assessment performed at least four weeks after the criteria for response are first met. Best Overall Response (OR) was determined based on the following combinations of repeat assessments: CR + CR = CR, CR + PR= SD, PD or PR, CR + SD =SD, CR+ PD = SD, CR + NEW= SD, PR + CR= PR, PR + PR= PR, PR+ SD= SD, PR + PD= SD, PR+ NEW = SD.

Outcome measures

Outcome measures
Measure	Sodium Cridanimod & Progestin Therapy n=11 Participants Sodium Cridanimod and progestin therapy (megestrol acetate) combination Sodium Cridanimod: The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative. progestin therapy: The study will investigate the use of progestin therapy in conjunction with Sodium Cridanimod
Objective Response Rate (ORR) Progressive Disease	8 Participants
Objective Response Rate (ORR) Stable Disease	3 Participants
Objective Response Rate (ORR) Control Response	0 Participants
Objective Response Rate (ORR) Partial Response	0 Participants

SECONDARY outcome

Timeframe: 24 months

Population: A total of 15 subjects entered Treatment Period 2, which included the 9 subjects who were PrR negative and the 6 subjects who were PrR positive and completed Treatment Period 1, and received treatment with IM sodium cridanimod in combination with oral progestin (megestrol acetate). Four (4) subjects withdrew from the study prior to meeting evaluable criteria for PFS.

Progressive Disease was assessed using RECIST Guideline (version 1.1) whereas at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Progression-free Survival (PFS) was defined as the duration of time from initiation of Treatment Period 2 (Day 0) until disease progression or death from any cause, whichever occurs first. For the purpose of analysis of PFS, subjects with an unknown response were censored.

Outcome measures

Outcome measures
Measure	Sodium Cridanimod & Progestin Therapy n=11 Participants Sodium Cridanimod and progestin therapy (megestrol acetate) combination Sodium Cridanimod: The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative. progestin therapy: The study will investigate the use of progestin therapy in conjunction with Sodium Cridanimod
Progression-free Survival (PFS) 001-15-01	168 days
Progression-free Survival (PFS) 001-30-01	54 days
Progression-free Survival (PFS) 001-39-05	85 days
Progression-free Survival (PFS) 001-45-02	85 days
Progression-free Survival (PFS) 001-48-01	166 days
Progression-free Survival (PFS) 001-01-03	31 days
Progression-free Survival (PFS) 001-39-07	32 days
Progression-free Survival (PFS) 001-39-08	88 days
Progression-free Survival (PFS) 001-43-01	60 days
Progression-free Survival (PFS) 001-45-01	144 days
Progression-free Survival (PFS) 001-47-03	73 days

SECONDARY outcome

Timeframe: 24 months

Population: A total of 15 subjects entered Treatment Period 2, which included the 9 subjects who were PrR negative and the 6 subjects who were PrR positive and completed Treatment Period 1, and received treatment with IM sodium cridanimod in combination with oral progestin (megestrol acetate). Four (4) subjects withdrew from the study and 8 subjects did not meet the criteria to be evaluable for duration of SD.

Stable Disease (SD) was assessed using RECIST Guideline (version 1.1) whereas neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Duration of Stable Disease was defined as the duration of time from initiation of Treatment Period 2 (Day 0) until the criteria for disease progression were first met. For the purpose of analysis of Duration of SD, subjects who died before documented progressive disease were censored.

Outcome measures

Outcome measures
Measure	Sodium Cridanimod & Progestin Therapy n=3 Participants Sodium Cridanimod and progestin therapy (megestrol acetate) combination Sodium Cridanimod: The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative. progestin therapy: The study will investigate the use of progestin therapy in conjunction with Sodium Cridanimod
Duration of Stable Disease 001-15-01	168 days
Duration of Stable Disease 001-48-01	166 days
Duration of Stable Disease 001-45-01	144 days

SECONDARY outcome

Timeframe: 12 months

Population: Fifteen (15) subjects who participated in Treatment Period 2 were eligible to be followed for OS; however, 4 of these subjects elected to not participate in the Follow-up Period because of withdrawal of consent (3 subjects) or other (1 subject, subject transferred to hospice). For the 11 subjects who participated in the Follow-up Period for OS, the time (in number of days) from the date of discontinuation to the time of death or last contact for survival information ranged from 32 to 457 days.

Once disease progression was documented in Treatment Period 2, subjects returned for the Safety Follow-up Visit four (4) weeks following the last treatment and continued to be followed for an additional 12-month period for overall survival. Overall Survival (OS) was defined as the duration of time from initiation of Treatment Period 2 (Day 0) until the subject's death from any cause. For the purpose of analysis of OS, if a subject is alive at the date of last contact the subject was censored at that date of contact.

Outcome measures

Outcome measures
Measure	Sodium Cridanimod & Progestin Therapy n=11 Participants Sodium Cridanimod and progestin therapy (megestrol acetate) combination Sodium Cridanimod: The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative. progestin therapy: The study will investigate the use of progestin therapy in conjunction with Sodium Cridanimod
Overall Survival (OS) 001-15-01	529 days
Overall Survival (OS) 001-30-01	411 days
Overall Survival (OS) 001-39-05	473 days
Overall Survival (OS) 001-45-02	541 days
Overall Survival (OS) 001-48-01	490 days
Overall Survival (OS) 001-01-03	77 days
Overall Survival (OS) 001-39-07	32 days
Overall Survival (OS) 001-39-08	394 days
Overall Survival (OS) 001-43-01	65 days
Overall Survival (OS) 001-45-01	386 days
Overall Survival (OS) 001-47-03	438 days

Adverse Events

Progestin Monotherapy

Serious events: 5 serious events

Other events: 13 other events

Deaths: 1 deaths

Sodium Cridanimod & Progestin Therapy

Serious events: 2 serious events

Other events: 12 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Progestin Monotherapy n=16 participants at risk Treatment Period 1 (Progestin Monotherapy): During Treatment Period 1, all subjects determined to be PrR positive will receive progestin monotherapy, megestrol acetate, for up to 24 weeks. Subjects will have an MRI or CT scan after 12 and 24 weeks of progestin monotherapy, with response to treatment being assessed according to RECIST 1.1 criteria. All subjects that achieve disease control confirmed by tumor assessment after Treatment Period 1, will be ineligible to enter Treatment Period 2. These subjects will be terminated from the trial and treated according to local standards of practice, which may include continued progestin therapy.	Sodium Cridanimod & Progestin Therapy n=15 participants at risk Treatment Period 2 (Combination Treatment): All subjects determined to be PrR negative at Screening and those who received at least 4 weeks of progestin monotherapy and who experienced disease progression at the conclusion of Treatment Period 1 will enter Treatment Period 2 of the study. During Treatment Period 2, subjects will receive Sodium Cridanimod in combination with continued progestin treatment, megestrol acetate. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria, with response assessments performed at 12-week intervals.
Vascular disorders Thromboembolic event DVT	6.2% 1/16 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	0.00% 0/15 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Gastrointestinal disorders Small bowel obstruction	6.2% 1/16 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	0.00% 0/15 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Infections and infestations bladder infection	6.2% 1/16 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	0.00% 0/15 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Nervous system disorders encephalopathy	6.2% 1/16 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	0.00% 0/15 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Metabolism and nutrition disorders hyponatremia	6.2% 1/16 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	0.00% 0/15 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Renal and urinary disorders increase creatinine	6.2% 1/16 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	0.00% 0/15 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Renal and urinary disorders Urinary Retention	0.00% 0/16 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	6.7% 1/15 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Renal and urinary disorders Hematuria	0.00% 0/16 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	6.7% 1/15 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) pleural effusion	6.2% 1/16 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	6.7% 1/15 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Gastrointestinal disorders worsening abdominal pain	6.2% 1/16 • Number of events 2 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	0.00% 0/15 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Respiratory, thoracic and mediastinal disorders compression atelectasis	0.00% 0/16 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	6.7% 1/15 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.
Respiratory, thoracic and mediastinal disorders difficulty breathing	0.00% 0/16 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.	6.7% 1/15 • Number of events 1 • The Investigator will assess subjects for Adverse Events (AEs) at each study visit from signing of Informed Consent through the End of Study Visit/Safety Follow-up Visit, an average of 24 months. All AEs observed or reported after the subject has provided informed consent must be recorded in the source data and reported on the eCRF regardless of causal relationship. No AEs will be recorded during the Safety Follow Up Period during which time only Overall Survival Rate is assessed.

Other adverse events

Additional Information

Dr. Curtis Lockshin

Xenetic Biosciences Inc

Phone: 781-778-7720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place