Trial Outcomes & Findings for Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone (NCT NCT02562755)
NCT ID: NCT02562755
Last Updated: 2020-12-16
Results Overview
Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), \>=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
459 participants
Primary outcome timeframe
From date of randomization to the date of first documented radiographic tumor progression up to 53 months
Results posted on
2020-12-16
Participant Flow
Participant milestones
| Measure |
Pexa-Vec Followed by Sorafenib
Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
Pexastimogene Devacirepvec (Pexa Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
Sorafenib
Sorafenib (400 mg twice daily) begins on Day 1.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
|---|---|---|
|
Overall Study
STARTED
|
234
|
225
|
|
Overall Study
Safety Population
|
218
|
217
|
|
Overall Study
COMPLETED
|
161
|
153
|
|
Overall Study
NOT COMPLETED
|
73
|
72
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
Baseline characteristics by cohort
| Measure |
Pexa-Vec Followed by Sorafenib
n=234 Participants
Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
Pexastimogene Devacirepvec (Pexa Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
Sorafenib
n=225 Participants
Sorafenib (400 mg twice daily) begins on Day 1.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
Total
n=459 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
|
133 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
101 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 10.05 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
229 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
448 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
|
|
Region of Enrollment
Singapore
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
34 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
61 participants
n=5 Participants
|
68 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Region of Enrollment
China
|
42 participants
n=5 Participants
|
40 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
ECOG performance status
0
|
146 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
ECOG performance status
1
|
88 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to the date of first documented radiographic tumor progression up to 53 monthsPercentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), \>=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Pexa-Vec Followed by Sorafenib
n=234 Participants
Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
Pexastimogene Devacirepvec (Pexa Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
Sorafenib
n=225 Participants
Sorafenib (400 mg twice daily) begins on Day 1.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
19.2 percentage of participants
|
20.9 percentage of participants
|
Adverse Events
Pexa-Vec Followed by Sorafenib
Serious events: 117 serious events
Other events: 218 other events
Deaths: 33 deaths
Sorafenib
Serious events: 77 serious events
Other events: 214 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Pexa-Vec Followed by Sorafenib
n=218 participants at risk
Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
Pexastimogene Devacirepvec (Pexa Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
Sorafenib
n=217 participants at risk
Sorafenib (400 mg twice daily) begins on Day 1.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Vascular disorders
Shock haemorrhagic
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Vascular disorders
Hypertension
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.8%
4/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.8%
4/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
1.4%
3/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.92%
2/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Pyrexia
|
3.7%
8/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Asthenia
|
1.4%
3/218 • From date of randomization to end of participation in the study, up to 53 months
|
2.3%
5/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
General physical health deterioration
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Fatigue
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Malaise
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Pain
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Chills
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Death NOS
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Psychiatric disorders
Confusional state
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Hepatic rupture
|
1.4%
3/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Blood bilirubin increased
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.8%
4/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Aspartate aminotransferase increased
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Blood creatinine increased
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Cardiac disorders
Angina pectoris
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Cardiac disorders
Aortic valve disease
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Cardiac disorders
Atrial flutter
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
4/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
3/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.3%
5/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.8%
4/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.92%
2/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Headache
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Paraesthesia
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Seizure
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Alcoholic seizure
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Presyncope
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Syncope
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Spinal cord compression
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
7/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.4%
3/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Ascites
|
3.7%
8/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.8%
4/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
4/218 • From date of randomization to end of participation in the study, up to 53 months
|
2.3%
5/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
3/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.4%
3/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.8%
4/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.8%
4/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Constipation
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.92%
2/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Nausea
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Colitis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Proctalgia
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
1.8%
4/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.4%
3/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Renal and urinary disorders
Renal failure
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Hepatic failure
|
5.0%
11/218 • From date of randomization to end of participation in the study, up to 53 months
|
3.7%
8/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.4%
3/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
1.4%
3/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Cholestasis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.92%
2/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.4%
3/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Gout
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Pneumonia
|
1.4%
3/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.8%
4/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Sepsis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.8%
4/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Peritonitis bacterial
|
1.8%
4/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Liver abscess
|
0.92%
2/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Urinary tract infection
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Bacteraemia
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Abdominal abscess
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Pneumonia necrotising
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Mycobacterial infection
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Peritonitis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Tonsillitis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Rectal abscess
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Post procedural infection
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Rhinitis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Oesophageal candidiasis
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Infection
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Influenza
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Device related infection
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Dengue fever
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.46%
1/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Paraplegia
|
0.46%
1/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
Other adverse events
| Measure |
Pexa-Vec Followed by Sorafenib
n=218 participants at risk
Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
Pexastimogene Devacirepvec (Pexa Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
Sorafenib
n=217 participants at risk
Sorafenib (400 mg twice daily) begins on Day 1.
Sorafenib: Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
20.2%
44/218 • From date of randomization to end of participation in the study, up to 53 months
|
18.0%
39/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Vascular disorders
Hypotension
|
16.1%
35/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.92%
2/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Pyrexia
|
84.4%
184/218 • From date of randomization to end of participation in the study, up to 53 months
|
12.9%
28/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Fatigue
|
29.8%
65/218 • From date of randomization to end of participation in the study, up to 53 months
|
29.5%
64/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Chills
|
32.6%
71/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.8%
4/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Asthenia
|
10.1%
22/218 • From date of randomization to end of participation in the study, up to 53 months
|
9.7%
21/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Influenza like illness
|
17.0%
37/218 • From date of randomization to end of participation in the study, up to 53 months
|
2.3%
5/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
Injection site pain
|
12.4%
27/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Psychiatric disorders
Insomnia
|
7.3%
16/218 • From date of randomization to end of participation in the study, up to 53 months
|
9.2%
20/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.5%
12/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.92%
2/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Investigations
Weight decreased
|
26.6%
58/218 • From date of randomization to end of participation in the study, up to 53 months
|
22.6%
49/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Investigations
Aspartate aminotransferase increased
|
13.8%
30/218 • From date of randomization to end of participation in the study, up to 53 months
|
18.0%
39/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Investigations
Blood bilirubin increased
|
10.1%
22/218 • From date of randomization to end of participation in the study, up to 53 months
|
15.2%
33/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Investigations
Alanine aminotransferase increased
|
7.8%
17/218 • From date of randomization to end of participation in the study, up to 53 months
|
13.4%
29/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Investigations
Platelet count decreased
|
6.9%
15/218 • From date of randomization to end of participation in the study, up to 53 months
|
6.9%
15/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Cardiac disorders
Sinus tachycardia
|
6.0%
13/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.4%
3/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Cardiac disorders
Tachycardia
|
7.3%
16/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.00%
0/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.2%
31/218 • From date of randomization to end of participation in the study, up to 53 months
|
11.5%
25/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
18/218 • From date of randomization to end of participation in the study, up to 53 months
|
5.1%
11/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.3%
16/218 • From date of randomization to end of participation in the study, up to 53 months
|
4.6%
10/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.6%
10/218 • From date of randomization to end of participation in the study, up to 53 months
|
5.5%
12/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
13/218 • From date of randomization to end of participation in the study, up to 53 months
|
4.1%
9/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Blood and lymphatic system disorders
Anaemia
|
15.1%
33/218 • From date of randomization to end of participation in the study, up to 53 months
|
10.6%
23/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Headache
|
15.1%
33/218 • From date of randomization to end of participation in the study, up to 53 months
|
10.6%
23/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Nervous system disorders
Dizziness
|
9.2%
20/218 • From date of randomization to end of participation in the study, up to 53 months
|
6.0%
13/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Diarrhoea
|
49.1%
107/218 • From date of randomization to end of participation in the study, up to 53 months
|
53.5%
116/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Nausea
|
33.9%
74/218 • From date of randomization to end of participation in the study, up to 53 months
|
29.0%
63/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Abdominal pain
|
28.4%
62/218 • From date of randomization to end of participation in the study, up to 53 months
|
27.6%
60/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Constipation
|
23.9%
52/218 • From date of randomization to end of participation in the study, up to 53 months
|
23.5%
51/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Vomiting
|
25.7%
56/218 • From date of randomization to end of participation in the study, up to 53 months
|
12.4%
27/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Ascites
|
21.1%
46/218 • From date of randomization to end of participation in the study, up to 53 months
|
16.6%
36/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
19.7%
43/218 • From date of randomization to end of participation in the study, up to 53 months
|
13.8%
30/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Abdominal distension
|
11.9%
26/218 • From date of randomization to end of participation in the study, up to 53 months
|
12.0%
26/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Stomatitis
|
7.8%
17/218 • From date of randomization to end of participation in the study, up to 53 months
|
11.1%
24/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
15/218 • From date of randomization to end of participation in the study, up to 53 months
|
6.0%
13/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Palmar plantar erythrodysaesthesia syndrome
|
33.5%
73/218 • From date of randomization to end of participation in the study, up to 53 months
|
45.6%
99/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.7%
32/218 • From date of randomization to end of participation in the study, up to 53 months
|
21.2%
46/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.6%
23/218 • From date of randomization to end of participation in the study, up to 53 months
|
12.9%
28/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
16/218 • From date of randomization to end of participation in the study, up to 53 months
|
7.8%
17/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
29/218 • From date of randomization to end of participation in the study, up to 53 months
|
7.8%
17/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.2%
20/218 • From date of randomization to end of participation in the study, up to 53 months
|
6.9%
15/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
19/218 • From date of randomization to end of participation in the study, up to 53 months
|
5.5%
12/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.4%
14/218 • From date of randomization to end of participation in the study, up to 53 months
|
5.5%
12/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.6%
10/218 • From date of randomization to end of participation in the study, up to 53 months
|
5.5%
12/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
11/218 • From date of randomization to end of participation in the study, up to 53 months
|
3.7%
8/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
39.0%
85/218 • From date of randomization to end of participation in the study, up to 53 months
|
29.5%
64/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
18/218 • From date of randomization to end of participation in the study, up to 53 months
|
8.8%
19/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.9%
15/218 • From date of randomization to end of participation in the study, up to 53 months
|
5.1%
11/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.3%
16/218 • From date of randomization to end of participation in the study, up to 53 months
|
4.6%
10/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.4%
14/218 • From date of randomization to end of participation in the study, up to 53 months
|
1.8%
4/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Rash pustular
|
17.9%
39/218 • From date of randomization to end of participation in the study, up to 53 months
|
0.92%
2/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
17/218 • From date of randomization to end of participation in the study, up to 53 months
|
10.6%
23/217 • From date of randomization to end of participation in the study, up to 53 months
|
|
General disorders
edema peripheral
|
12.4%
27/218 • From date of randomization to end of participation in the study, up to 53 months
|
9.7%
21/217 • From date of randomization to end of participation in the study, up to 53 months
|
Additional Information
Kyoung Soo Ha, Senior Medical Director
SillaJen Biotherapeutics Inc.
Phone: +1-415-281-8886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place