Trial Outcomes & Findings for Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Hepatocelluar Carcinoma Patients (NCT NCT00699816)
NCT ID: NCT00699816
Last Updated: 2023-07-11
Results Overview
RFS was measured from the date of randomization to the first recurrence or to death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
230 participants
Primary outcome timeframe
Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Results posted on
2023-07-11
Participant Flow
This phase 3 clinical study was a multicenter, randomized, open-labeled trial. The study was conducted at 5 university affiliated hospitals in Korea. All eligible participants were assigned randomly, in a 1:1 ratio, to receive adjuvant adoptive immune therapy using a CIK cell agent or no adjuvant treatment.
Participant milestones
| Measure |
Immunotherapy Group
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
115
|
|
Overall Study
COMPLETED
|
114
|
112
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Immunotherapy Group
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
3
|
Baseline Characteristics
Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Hepatocelluar Carcinoma Patients
Baseline characteristics by cohort
| Measure |
Immunotherapy Group
n=114 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
n=112 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
55.4 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
55.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
114 participants
n=5 Participants
|
112 participants
n=7 Participants
|
226 participants
n=5 Participants
|
|
Treatment modality
Percutaneous ethanol injection
|
13 participants
n=5 Participants
|
4 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Treatment modality
Radiofrequency ablation
|
69 participants
n=5 Participants
|
70 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Treatment modality
Surgical resection
|
32 participants
n=5 Participants
|
38 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
HCC stage
Stage I
|
98 participants
n=5 Participants
|
94 participants
n=7 Participants
|
192 participants
n=5 Participants
|
|
HCC stage
Stage II
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Number of HCC
>3 or =3
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Number of HCC
<3
|
112 participants
n=5 Participants
|
110 participants
n=7 Participants
|
222 participants
n=5 Participants
|
|
Size of HCC
|
1.8 centimeter
n=5 Participants
|
2.3 centimeter
n=7 Participants
|
2.0 centimeter
n=5 Participants
|
|
ECOG performance status
0
|
81 participants
n=5 Participants
|
81 participants
n=7 Participants
|
162 participants
n=5 Participants
|
|
ECOG performance status
1
|
33 participants
n=5 Participants
|
31 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Cause of liver disease
HBV infection only
|
96 participants
n=5 Participants
|
90 participants
n=7 Participants
|
186 participants
n=5 Participants
|
|
Cause of liver disease
HCV infection only
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Cause of liver disease
HBV and HCV
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Cause of liver disease
Co-infection (Others)
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Cause of liver disease
Co-infection (Cirrhosis)
|
76 participants
n=5 Participants
|
70 participants
n=7 Participants
|
146 participants
n=5 Participants
|
|
Alpha fetoprotein level
|
5.2 ng/mL
n=5 Participants
|
5.4 ng/mL
n=7 Participants
|
5.3 ng/mL
n=5 Participants
|
|
PIVKA-II
|
19.0 mAU/mL
n=5 Participants
|
18.0 mAU/mL
n=7 Participants
|
18.5 mAU/mL
n=5 Participants
|
|
Aspartate aminotransferase level
|
33.0 IU/L
n=5 Participants
|
34.0 IU/L
n=7 Participants
|
33.5 IU/L
n=5 Participants
|
|
Alanine aminotransferase level
|
33.0 IU/L
n=5 Participants
|
33.0 IU/L
n=7 Participants
|
33.0 IU/L
n=5 Participants
|
|
Alkaline phosphatase level
|
82.5 IU/L
n=5 Participants
|
82.0 IU/L
n=7 Participants
|
82.3 IU/L
n=5 Participants
|
|
Albumin level
|
4.1 g/dL
n=5 Participants
|
4.1 g/dL
n=7 Participants
|
4.1 g/dL
n=5 Participants
|
|
Total bilirubin level
|
0.8 mg/dL
n=5 Participants
|
0.8 mg/dL
n=7 Participants
|
0.8 mg/dL
n=5 Participants
|
|
Prothrombin time
|
13.7 seconds
n=5 Participants
|
13.9 seconds
n=7 Participants
|
13.8 seconds
n=5 Participants
|
|
Creatinine level
|
0.9 mg/dL
n=5 Participants
|
0.9 mg/dL
n=7 Participants
|
0.9 mg/dL
n=5 Participants
|
|
Platelet
|
116.5 x 10^3/mm^3
n=5 Participants
|
141.0 x 10^3/mm^3
n=7 Participants
|
128.6 x 10^3/mm^3
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)RFS was measured from the date of randomization to the first recurrence or to death from any cause.
Outcome measures
| Measure |
Immunotherapy Group
n=114 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
n=112 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Recurrence Free Survival(RFS)
|
44.0 months
Interval 42.46 to 44.54
|
30.0 months
Interval 28.25 to 31.75
|
PRIMARY outcome
Timeframe: Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.
Outcome measures
| Measure |
Immunotherapy Group
n=114 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
n=112 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Recurrence Free Survival(RFS) Rate
RFS rate 12 months
|
79.9 percentage of participants
|
65.1 percentage of participants
|
|
Recurrence Free Survival(RFS) Rate
RFS rate 24 months
|
72.5 percentage of participants
|
53.8 percentage of participants
|
|
Recurrence Free Survival(RFS) Rate
RFS rate 36 months
|
60.9 percentage of participants
|
44.3 percentage of participants
|
|
Recurrence Free Survival(RFS) Rate
RFS rate 48 months
|
49.6 percentage of participants
|
39.6 percentage of participants
|
SECONDARY outcome
Timeframe: Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)Overall survival was measured from the date of randomization until death from any cause.
Outcome measures
| Measure |
Immunotherapy Group
n=114 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
n=112 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Overall Survival(OS)
|
NA months
At the time of the date cut-off date, 15 deaths had occurred in the efficacy population. Median OS was not reached.
|
NA months
At the time of the date cut-off date, 15 deaths had occurred in the efficacy population. Median OS was not reached.
|
SECONDARY outcome
Timeframe: Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)Cancer-specific survival was measured from the date of randomization until death resulting from HCC.
Outcome measures
| Measure |
Immunotherapy Group
n=114 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
n=112 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Cancer-specific Survivals
|
NA months
At the time of the date cut-off date, 15 deaths had occurred in the efficacy population. Median Cancer-specific survival was not reached.
|
NA months
At the time of the date cut-off date, 15 deaths had occurred in the efficacy population. Median Cancer-specific survival was not reached.
|
SECONDARY outcome
Timeframe: Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)Overall survival rate was measured from the date of randomization until death from any cause.
Outcome measures
| Measure |
Immunotherapy Group
n=114 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
n=112 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Overall Survival(OS) Rate
OS rate 12 months
|
100.0 percentage of participants
|
98.0 percentage of participants
|
|
Overall Survival(OS) Rate
OS rate 24 months
|
100.0 percentage of participants
|
91.8 percentage of participants
|
|
Overall Survival(OS) Rate
OS rate 36 months
|
97.5 percentage of participants
|
88.1 percentage of participants
|
|
Overall Survival(OS) Rate
OS rate 48 months
|
95.9 percentage of participants
|
84.8 percentage of participants
|
SECONDARY outcome
Timeframe: Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.
Outcome measures
| Measure |
Immunotherapy Group
n=114 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
n=112 Participants
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Cancer-specific Survival Rate
Cancer-specific survival rate 12 months
|
100.0 percentage of participants
|
98.0 percentage of participants
|
|
Cancer-specific Survival Rate
Cancer-specific survival rate 24 months
|
100.0 percentage of participants
|
94.9 percentage of participants
|
|
Cancer-specific Survival Rate
Cancer-specific survival rate 36 months
|
98.8 percentage of participants
|
91.0 percentage of participants
|
|
Cancer-specific Survival Rate
Cancer-specific survival rate 48 months
|
97.2 percentage of participants
|
87.5 percentage of participants
|
Adverse Events
Immunotherapy Group
Serious events: 9 serious events
Other events: 71 other events
Deaths: 0 deaths
Control Group
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immunotherapy Group
n=115 participants at risk
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
n=115 participants at risk
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Surgical and medical procedures
High frequency ablation
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Hepatobiliary disorders
Hepatic vein stenosis
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Infections and infestations
Herpes zoster
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
Other adverse events
| Measure |
Immunotherapy Group
n=115 participants at risk
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
|
Control Group
n=115 participants at risk
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation\[RFA\], or percutaneous ethanol injection\[PEI\]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
6/115 • Number of events 6 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
3.5%
4/115 • Number of events 5 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
1.7%
2/115 • Number of events 2 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Infections and infestations
Body tinea
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
5/115 • Number of events 5 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
3.5%
4/115 • Number of events 4 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
2/115 • Number of events 2 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
4.3%
5/115 • Number of events 5 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
General disorders
Chills
|
9.6%
11/115 • Number of events 24 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
General disorders
Pyrexia
|
10.4%
12/115 • Number of events 22 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Nervous system disorders
Dizziness
|
4.3%
5/115 • Number of events 5 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
2.6%
3/115 • Number of events 4 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Infections and infestations
Herpes zoster
|
1.7%
2/115 • Number of events 2 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
5/115 • Number of events 6 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.2%
6/115 • Number of events 6 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
3.5%
4/115 • Number of events 4 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
General disorders
Fatigue
|
9.6%
11/115 • Number of events 12 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
General disorders
Asthenia
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
2/115 • Number of events 2 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
General disorders
Chest discomfort
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Vascular disorders
Hypertension
|
1.7%
2/115 • Number of events 2 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
1.7%
2/115 • Number of events 2 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
1.7%
2/115 • Number of events 2 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Psychiatric disorders
Insomnia
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
2/115 • Number of events 4 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
1.7%
2/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
1.7%
2/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
2/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
3/115 • Number of events 4 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
1.7%
2/115 • Number of events 2 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Nervous system disorders
Headache
|
2.6%
3/115 • Number of events 4 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Investigations
Weight decreased
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Investigations
Weight increased
|
1.7%
2/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.6%
3/115 • Number of events 3 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.2%
6/115 • Number of events 6 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.87%
1/115 • Number of events 1 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
0.00%
0/115 • Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
|
Additional Information
Jung-Hwan Yoon, MD, PhD
Seoul National University College of Medicine
Phone: +82-2-2072-2228
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place