Trial Outcomes & Findings for Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma (NCT NCT01394939)
NCT ID: NCT01394939
Last Updated: 2021-01-08
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
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Scans Every 8 weeks until radiographic progression was confirmed by the site.
Results posted on
2021-01-08
Participant Flow
2 patients out of 52 enrolled experienced no study related Adverse Event (AE) and was not included in the started population.
Participant milestones
| Measure |
Single Agent_ Cohort 1
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Cohort 1: JX-594 3 x 10\^8 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
Irinotecan: 180 mg/m2 IV every 2 weeks.
JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
25
|
4
|
17
|
|
Overall Study
COMPLETED
|
3
|
15
|
4
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
10
|
0
|
7
|
Reasons for withdrawal
| Measure |
Single Agent_ Cohort 1
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Cohort 1: JX-594 3 x 10\^8 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
Irinotecan: 180 mg/m2 IV every 2 weeks.
JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
0
|
2
|
|
Overall Study
Death
|
0
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
2
|
|
Overall Study
Others
|
0
|
2
|
0
|
3
|
Baseline Characteristics
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
Baseline characteristics by cohort
| Measure |
Single Agent_ Cohort 1
n=4 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594 3 x 10\^8 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=25 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=4 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=17 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 8.06 • n=99 Participants
|
58.3 years
STANDARD_DEVIATION 11.84 • n=107 Participants
|
58.8 years
STANDARD_DEVIATION 13.74 • n=206 Participants
|
58.6 years
STANDARD_DEVIATION 10.42 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 11.05 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
44 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Scans Every 8 weeks until radiographic progression was confirmed by the site.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.
Outcome measures
| Measure |
Single Agent_ Cohort 1
n=4 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Cohort 1: JX-594 3 x 10\^8 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=25 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=4 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=17 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Single Agent_ Cohort 1
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Single Agent_Cohort 2
Serious events: 10 serious events
Other events: 25 other events
Deaths: 2 deaths
Combination_Cohort 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Combination_Cohort 4
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Agent_ Cohort 1
n=4 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 1: Pexa-Vec 3 x 108 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=25 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 2: Pexa-Vec 3 x 109 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=4 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Irinotecan: 180 mg/m2 IV every 2 weeks.
Cohort 3: Pexa-Vec 3 x 108 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=17 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 4: Pexa-Vec 1 x 109 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
General disorders
Disease progression
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Pyrexia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Investigations
Troponin increased
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
Other adverse events
| Measure |
Single Agent_ Cohort 1
n=4 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 1: Pexa-Vec 3 x 108 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=25 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 2: Pexa-Vec 3 x 109 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=4 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Irinotecan: 180 mg/m2 IV every 2 weeks.
Cohort 3: Pexa-Vec 3 x 108 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=17 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 4: Pexa-Vec 1 x 109 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
General disorders
Disease progression
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Fatigue
|
50.0%
2/4 • 2 years
|
28.0%
7/25 • 2 years
|
100.0%
4/4 • 2 years
|
70.6%
12/17 • 2 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • 2 years
|
24.0%
6/25 • 2 years
|
50.0%
2/4 • 2 years
|
35.3%
6/17 • 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
50.0%
2/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
17.6%
3/17 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Cardiac disorders
Tachycardia
|
50.0%
2/4 • 2 years
|
24.0%
6/25 • 2 years
|
75.0%
3/4 • 2 years
|
41.2%
7/17 • 2 years
|
|
Cardiac disorders
Ventricular hypokinesia
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Eye disorders
Eyepain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Eye disorders
Ocular icterus
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • 2 years
|
16.0%
4/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
75.0%
3/4 • 2 years
|
28.0%
7/25 • 2 years
|
50.0%
2/4 • 2 years
|
29.4%
5/17 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • 2 years
|
12.0%
3/25 • 2 years
|
75.0%
3/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • 2 years
|
12.0%
3/25 • 2 years
|
50.0%
2/4 • 2 years
|
29.4%
5/17 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • 2 years
|
12.0%
3/25 • 2 years
|
50.0%
2/4 • 2 years
|
47.1%
8/17 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • 2 years
|
52.0%
13/25 • 2 years
|
100.0%
4/4 • 2 years
|
82.4%
14/17 • 2 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
50.0%
2/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • 2 years
|
48.0%
12/25 • 2 years
|
100.0%
4/4 • 2 years
|
58.8%
10/17 • 2 years
|
|
General disorders
Asthenia
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Catheter site pruritus
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Chills
|
100.0%
4/4 • 2 years
|
76.0%
19/25 • 2 years
|
100.0%
4/4 • 2 years
|
88.2%
15/17 • 2 years
|
|
General disorders
Device occlusion
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
General disorders
Hypothermia
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Injection site pain
|
25.0%
1/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Localised oedema
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Malaise
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
50.0%
2/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Mass
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Medical device complication
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
17.6%
3/17 • 2 years
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • 2 years
|
28.0%
7/25 • 2 years
|
75.0%
3/4 • 2 years
|
23.5%
4/17 • 2 years
|
|
General disorders
Pain
|
25.0%
1/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
General disorders
Pyrexia
|
100.0%
4/4 • 2 years
|
92.0%
23/25 • 2 years
|
100.0%
4/4 • 2 years
|
100.0%
17/17 • 2 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Infections and infestations
Folliculitis
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Infections and infestations
Gingivitis
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Infections and infestations
Lip infection
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
17.6%
3/17 • 2 years
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Infections and infestations
Rash pustular
|
75.0%
3/4 • 2 years
|
44.0%
11/25 • 2 years
|
25.0%
1/4 • 2 years
|
35.3%
6/17 • 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Injury, poisoning and procedural complications
Splinter
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • 2 years
|
12.0%
3/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • 2 years
|
12.0%
3/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • 2 years
|
12.0%
3/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • 2 years
|
16.0%
4/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Blood bilirubin increased
|
50.0%
2/4 • 2 years
|
32.0%
8/25 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Investigations
Haematocrit decreased
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Investigations
International normalised ratio increased
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
75.0%
3/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Troponin increased
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
Weight decreased
|
25.0%
1/4 • 2 years
|
12.0%
3/25 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Investigations
Weight increased
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • 2 years
|
16.0%
4/25 • 2 years
|
100.0%
4/4 • 2 years
|
41.2%
7/17 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • 2 years
|
4.0%
1/25 • 2 years
|
25.0%
1/4 • 2 years
|
23.5%
4/17 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • 2 years
|
8.0%
2/25 • 2 years
|
25.0%
1/4 • 2 years
|
23.5%
4/17 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
17.6%
3/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
29.4%
5/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
25.0%
1/4 • 2 years
|
17.6%
3/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • 2 years
|
20.0%
5/25 • 2 years
|
25.0%
1/4 • 2 years
|
17.6%
3/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • 2 years
|
4.0%
1/25 • 2 years
|
25.0%
1/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
50.0%
2/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Nervous system disorders
Extensor plantar response
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 2 years
|
48.0%
12/25 • 2 years
|
75.0%
3/4 • 2 years
|
41.2%
7/17 • 2 years
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
17.6%
3/17 • 2 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Psychiatric disorders
Encopresis
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • 2 years
|
8.0%
2/25 • 2 years
|
25.0%
1/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
50.0%
2/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Renal and urinary disorders
Urinary tract pain
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 2 years
|
12.0%
3/25 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • 2 years
|
24.0%
6/25 • 2 years
|
50.0%
2/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
50.0%
2/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
50.0%
2/4 • 2 years
|
35.3%
6/17 • 2 years
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Skin and subcutaneous tissue disorders
Capillaritis
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 2 years
|
12.0%
3/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rash maculo-papular
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • 2 years
|
8.0%
2/25 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • 2 years
|
4.0%
1/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • 2 years
|
20.0%
5/25 • 2 years
|
50.0%
2/4 • 2 years
|
41.2%
7/17 • 2 years
|
|
Vascular disorders
Hypotension
|
50.0%
2/4 • 2 years
|
64.0%
16/25 • 2 years
|
75.0%
3/4 • 2 years
|
64.7%
11/17 • 2 years
|
|
Vascular disorders
Phlebitis
|
25.0%
1/4 • 2 years
|
0.00%
0/25 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
Additional Information
Kyoung Soo Ha, Head of Clinical Development
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