Trial Outcomes & Findings for Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC (NCT NCT04011033)
NCT ID: NCT04011033
Last Updated: 2024-10-08
Results Overview
PFS is the duration from the date of enrolled into clinical trial to the date of first documentation of tumor progression. Progression is defined using Modified RECIST (mRECIST),as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
From date of enrollment to disease progression according to mRECIST, or death from any cause, whichever occurred first，approximately 2 years.
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
TAE/TACE+iNKT for Unresectable HCC
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
TAE/TACE+iNKT for Unresectable HCC
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC
Baseline characteristics by cohort
| Measure |
TAE/TACE+iNKT for Unresectable HCC
n=27 Participants
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
n=27 Participants
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
Total
n=54 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
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
China
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of enrollment to disease progression according to mRECIST, or death from any cause, whichever occurred first，approximately 2 years.PFS is the duration from the date of enrolled into clinical trial to the date of first documentation of tumor progression. Progression is defined using Modified RECIST (mRECIST),as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started.
Outcome measures
| Measure |
TAE/TACE+iNKT for Unresectable HCC
n=27 Participants
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
n=27 Participants
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
|---|---|---|
|
Progression-Free Survival(PFS)
|
5.7 months
Interval 4.3 to 7.0
|
2.7 months
Interval 2.3 to 3.2
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months.OS is the duration from the date of enrollment to the date of death due to any causes.
Outcome measures
| Measure |
TAE/TACE+iNKT for Unresectable HCC
n=27 Participants
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
n=27 Participants
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
|---|---|---|
|
Overall Survival(OS)
|
25.9 months
Interval 12.4 to 44.4
|
17.3 months
Interval 7.5 to 27.6
|
SECONDARY outcome
Timeframe: Evaluation was performed at the 12th week after the start of the treatment.ORR is the proportion of patients who had a response rate including complete remission (CR) and partial remission (PR) evaluated by imaging according to mRECIST for target lesions and assessed by MRI/CT: Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions；Partial Response (PR), At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
TAE/TACE+iNKT for Unresectable HCC
n=27 Participants
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
n=27 Participants
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
|---|---|---|
|
Objective Response Rate(ORR)
|
14 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Evaluation was performed at the 12th week after the start of the treatment.DCR is the proportion of patients who had a response rate including complete remission (CR), partial remission (PR) and disease stabilization (SD) evaluated by imaging according to mRECIST for target lesions and assessed by MRI/CT: Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions；Partial Response (PR), At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions;Stable disease(SD), Any cases that do not qualify for either partial response or progressive disease. Disease Control Rate (DCR) = CR + PR + SD.
Outcome measures
| Measure |
TAE/TACE+iNKT for Unresectable HCC
n=27 Participants
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
n=27 Participants
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
23 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.The severities of AEs will be divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
TAE/TACE+iNKT for Unresectable HCC
n=27 Participants
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
n=27 Participants
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
|---|---|---|
|
Adverse Events(AEs)
Cholesterol high(Any Grade)
|
1 Participants
|
1 Participants
|
|
Adverse Events(AEs)
Chill (Any Grade)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Chill (≧ Grade 3)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Fatigue(Any Grade)
|
3 Participants
|
5 Participants
|
|
Adverse Events(AEs)
Fatigue(≧ Grade 3)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Fever (Any Grade)
|
3 Participants
|
5 Participants
|
|
Adverse Events(AEs)
Fever (≧ Grade 3)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Injection site reaction(Any Grade)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Injection site reaction (≧ Grade 3)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Callosity(Any Grade)
|
4 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Callosity(≧ Grade 3)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Activation time of partial prothrombin (Any Grade)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Activation time of partial prothrombin (≧ Grade 3)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Alanine aminotransferase increased (Any Grade)
|
1 Participants
|
8 Participants
|
|
Adverse Events(AEs)
Alanine aminotransferase increased (≧ Grade 3)
|
0 Participants
|
2 Participants
|
|
Adverse Events(AEs)
Aspartate aminotransferase increased (Any Grade)
|
4 Participants
|
5 Participants
|
|
Adverse Events(AEs)
Aspartate aminotransferase increased (≧ Grade 3)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Blood bilirubin increased (Any Grade)
|
3 Participants
|
6 Participants
|
|
Adverse Events(AEs)
Blood bilirubin increased (≧ Grade 3)
|
0 Participants
|
2 Participants
|
|
Adverse Events(AEs)
Alkaline phosphatase increased (Any Grade)
|
1 Participants
|
2 Participants
|
|
Adverse Events(AEs)
Alkaline phosphatase increased (≧ Grade 3)
|
0 Participants
|
0 Participants
|
|
Adverse Events(AEs)
Glutamyl transpeptidase increased (Any Grade)
|
6 Participants
|
6 Participants
|
|
Adverse Events(AEs)
Glutamyl transpeptidase increased (≧ Grade 3)
|
1 Participants
|
1 Participants
|
|
Adverse Events(AEs)
Cholesterol high(≧ Grade 3)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Data will be collected at baseline and every 4 weeks until disease progression, then every 8 weeks for up to 60 weeks.EORTC QLQ-C30: European Organization for Research on Treatment of Cancer Quality of Life Questionnare-Core 30. The totally 30 items spread out over five functional scales (15 items), three symptom scales (7 items), a global health status/QoL scale (2 items), and six single items. 1-28 item ranges 1: not at all, 2: a little, 3: quite a lit, 4: very much; 29-30 item ranges 1-7 from very poor to excellent. Raw score (RS) is an average of all items in each area. Standardized score is in the range of 0-100 by formula SS=\[1-(RS-1)/n\] x100 (function) or SS=\[（RS-1）/n\]x100 (symptom or overall health) respectively. A high scale score represents a higher/healthy response level. Time to deterioration was defined as a decrease from baseline of 10 points or more on the EORTC QLQ-C30 maintained for two consecutive assessments.
Outcome measures
| Measure |
TAE/TACE+iNKT for Unresectable HCC
n=27 Participants
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
n=27 Participants
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
|---|---|---|
|
Time to Quality of Life (QoL) Deterioration
|
9.2 months
Interval 6.0 to 13.3
|
3.0 months
Interval 2.9 to 3.0
|
Adverse Events
TAE/TACE+iNKT for Unresectable HCC
Serious events: 0 serious events
Other events: 14 other events
Deaths: 5 deaths
TAE/TACE for Unresectable HCC
Serious events: 0 serious events
Other events: 15 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAE/TACE+iNKT for Unresectable HCC
n=27 participants at risk
TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.
Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
TAE/TACE for Unresectable HCC
n=27 participants at risk
TAE/TACE will be conducted at 0th week and 4th week.
TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week.
|
|---|---|---|
|
General disorders
Fatigue
|
11.1%
3/27 • Number of events 3 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
18.5%
5/27 • Number of events 5 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
|
General disorders
Fever
|
11.1%
3/27 • Number of events 3 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
18.5%
5/27 • Number of events 5 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
|
General disorders
Callosity
|
14.8%
4/27 • Number of events 4 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
0.00%
0/27 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • Number of events 1 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
29.6%
8/27 • Number of events 8 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
|
Investigations
Aspartate aminotransferase increased
|
14.8%
4/27 • Number of events 4 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
18.5%
5/27 • Number of events 5 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
|
Investigations
Blood bilirubin increased
|
11.1%
3/27 • Number of events 3 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
22.2%
6/27 • Number of events 6 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
|
Investigations
Alkaline phosphatase increased
|
3.7%
1/27 • Number of events 1 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
7.4%
2/27 • Number of events 2 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
|
Investigations
Glutamyl transpeptidase increased
|
22.2%
6/27 • Number of events 6 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
22.2%
6/27 • Number of events 6 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
|
Investigations
Cholesterol high
|
3.7%
1/27 • Number of events 1 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
3.7%
1/27 • Number of events 1 • The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place