Trial Outcomes & Findings for A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers (NCT NCT01743469)
NCT ID: NCT01743469
Last Updated: 2019-01-08
Results Overview
Progression (prog.) defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in sum of longest diameter of target lesions,or a measurable increase in a nontarget lesion,or appearance of new lesions. 'Progressed or Died' when time between start of study drug \&first date of the following events was ≤ to analysis timepoint +3 days:1) Disease prog. according to central review using RECIST v1.1:date of disease prog. or if missing,first exam date of the visit showing a disease prog.2) Death due to any cause. 'Neither progressed, nor died' if central assessment by RECIST v1.1 confirmed no disease prog. was observed at the considered timepoint,i.e. time between start of study medication \&last examination/visit date of complete response (CR),partial response (PR) or stable disease (SD) ≥ analysis timepoint 7days.In other cases, such as patient withdrawal due to AEs without tumor assessment proving prog.,the patient was considered as 'not assessable'.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
201 participants
Primary outcome timeframe
Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort).
Results posted on
2019-01-08
Participant Flow
Patients were recruited from 24 investigational sites in Belgium, Canada, the United Kingdom, Spain and France. The first patient was enrolled in December 2012 and the study was completed in April 2016.
In the hepatocellular carcinoma cohort 67 patients were screened, of whom 53 were treated with tasquinimod. In the ovarian carcinoma cohort 63 were screened, of whom 55 were treated. In the renal cell carcinoma cohort 44 were screened, of whom 38 were treated. In the gastric carcinoma cohort 27 were screened, of whom 21 were treated.
Participant milestones
| Measure |
Hepatocellular Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Active Treatment Phase
STARTED
|
53
|
55
|
38
|
21
|
|
Active Treatment Phase
COMPLETED
|
0
|
0
|
0
|
0
|
|
Active Treatment Phase
NOT COMPLETED
|
53
|
55
|
38
|
21
|
|
Follow-up Period - Post-Treatment
STARTED
|
51
|
53
|
37
|
21
|
|
Follow-up Period - Post-Treatment
COMPLETED
|
6
|
5
|
14
|
5
|
|
Follow-up Period - Post-Treatment
NOT COMPLETED
|
45
|
48
|
23
|
16
|
Reasons for withdrawal
| Measure |
Hepatocellular Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Active Treatment Phase
Adverse Event
|
10
|
5
|
8
|
1
|
|
Active Treatment Phase
Disease Progression
|
40
|
47
|
30
|
20
|
|
Active Treatment Phase
Withdrawal by Subject
|
2
|
3
|
0
|
0
|
|
Active Treatment Phase
Missing
|
1
|
0
|
0
|
0
|
|
Follow-up Period - Post-Treatment
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Follow-up Period - Post-Treatment
Death
|
43
|
47
|
22
|
16
|
|
Follow-up Period - Post-Treatment
Lost to Follow-up
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers
Baseline characteristics by cohort
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
Tasquinimod: 1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Total
n=167 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
|
19 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
89 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
78 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
77 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
90 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
138 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
27 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
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 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
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
130 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
|
Region of Enrollment
Belgium
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
Region of Enrollment
France
|
43 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
66 Participants
n=31 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort).Population: ITT population: All treated patients i.e. all patients who had received at least one dose of tasquinimod. An additional patient was included in the hepatocellular carcinoma cohort, since the 52nd (last patient planned in the protocol) and 53rd were screened at the same time. This 53rd was not included in the primary analysis.
Progression (prog.) defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in sum of longest diameter of target lesions,or a measurable increase in a nontarget lesion,or appearance of new lesions. 'Progressed or Died' when time between start of study drug \&first date of the following events was ≤ to analysis timepoint +3 days:1) Disease prog. according to central review using RECIST v1.1:date of disease prog. or if missing,first exam date of the visit showing a disease prog.2) Death due to any cause. 'Neither progressed, nor died' if central assessment by RECIST v1.1 confirmed no disease prog. was observed at the considered timepoint,i.e. time between start of study medication \&last examination/visit date of complete response (CR),partial response (PR) or stable disease (SD) ≥ analysis timepoint 7days.In other cases, such as patient withdrawal due to AEs without tumor assessment proving prog.,the patient was considered as 'not assessable'.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=52 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts).
|
26.9 percentage of participants
Interval 15.57 to 41.02
|
7.3 percentage of participants
Interval 2.02 to 17.59
|
13.2 percentage of participants
Interval 4.41 to 28.09
|
9.5 percentage of participants
Interval 1.17 to 30.38
|
SECONDARY outcome
Timeframe: Week 16.Population: ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
PFS rate was defined as the percentage of patients who had neither progressed nor died. Tumour progression was assessed centrally using the Choi criteria. Response was measured using the following criteria: CR: Disappearance of all lesions, no new lesions; PR: A decrease in size ≥10% or a decrease in tumour attenuation (Hounsfield unit \[HU\]) ≥15% on CT, no new lesions, no obvious progression of non-measurable disease; SD: Does not meet criteria for CR, PR, or progressive disease (PD), no symptomatic deterioration attributed to tumour progression; PD: An increase in tumour size ≥10% and does not meet criteria of PR by tumour attenuation on CT, new lesions.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort).
|
20.8 percentage of participants
Interval 10.84 to 34.11
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).Population: ITT population: all treated patients i.e. all patients who had received at lease one dose of tasquinimod.
Best overall response was derived as the best overall response documented before the prespecified timepoint (gastric carcinoma cohort: 12 weeks; Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Best overall response: PR (centrally assessed)
|
1.9 percentage of participants
Interval 0.05 to 10.07
|
1.8 percentage of participants
Interval 0.05 to 9.72
|
0 percentage of participants
No patients had PR as best overall response, unable to compute 95% CI.
|
0 percentage of participants
No patients had PR as best overall response, unable to compute 95% CI.
|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Best overall response: SD (centrally assessed)
|
54.7 percentage of participants
Interval 40.45 to 68.44
|
49.1 percentage of participants
Interval 35.35 to 62.93
|
47.4 percentage of participants
Interval 30.98 to 64.18
|
23.8 percentage of participants
Interval 8.22 to 47.17
|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Best overall response: PD (centrally assessed)
|
34.0 percentage of participants
Interval 21.52 to 48.27
|
41.8 percentage of participants
Interval 28.65 to 55.89
|
44.7 percentage of participants
Interval 28.62 to 61.7
|
66.7 percentage of participants
Interval 43.03 to 85.41
|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Best overall response: NE (centrally assessed)
|
9.4 percentage of participants
Interval 3.13 to 20.66
|
7.3 percentage of participants
Interval 2.02 to 17.59
|
7.9 percentage of participants
Interval 1.66 to 21.38
|
9.5 percentage of participants
Interval 1.17 to 30.38
|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Response rate (CR or PR) (centrally assessed)
|
1.9 percentage of participants
Interval 0.05 to 10.07
|
1.8 percentage of participants
Interval 0.05 to 9.72
|
0 percentage of participants
No patients had CR or PR as best overall response, unable to compute 95% CI.
|
0 percentage of participants
No patients had CR or PR as best overall response, unable to compute 95% CI.
|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Best overall response: PR (locally assessed)
|
0 percentage of participants
No patients had PR as best overall response, unable to compute 95% CI.
|
0 percentage of participants
No patients had PR as best overall response, unable to compute 95% CI.
|
0 percentage of participants
No patients had PR as best overall response, unable to compute 95% CI.
|
0 percentage of participants
No patients had PR as best overall response, unable to compute 95% CI.
|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Best overall response: SD (locally assessed)
|
52.8 percentage of participants
Interval 38.64 to 66.7
|
32.7 percentage of participants
Interval 20.68 to 46.71
|
39.5 percentage of participants
Interval 24.04 to 56.61
|
14.3 percentage of participants
Interval 3.05 to 36.34
|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Best overall response: PD (locally assessed)
|
43.4 percentage of participants
Interval 29.84 to 57.72
|
61.8 percentage of participants
Interval 47.73 to 74.59
|
57.9 percentage of participants
Interval 40.82 to 73.69
|
81.0 percentage of participants
Interval 58.09 to 94.55
|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Best overall response: NE (locally assessed)
|
3.8 percentage of participants
Interval 0.46 to 12.98
|
5.5 percentage of participants
Interval 1.14 to 15.12
|
2.6 percentage of participants
Interval 0.07 to 13.81
|
4.8 percentage of participants
Interval 0.12 to 23.82
|
|
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
Response rate (CR or PR) (locally assessed)
|
0 percentage of participants
No patients had CR or PR as best overall response, unable to compute 95% CI.
|
0 percentage of participants
No patients had CR or PR as best overall response, unable to compute 95% CI.
|
0 percentage of participants
No patients had CR or PR as best overall response, unable to compute 95% CI.
|
0 percentage of participants
No patients had CR or PR as best overall response, unable to compute 95% CI.
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression, up to 36 months.Population: ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Per Choi Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=10% decrease in the sum of the longest diameter of target lesions; Progression, as a 10% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
Best overall response: PR
|
20.8 percentage of participants
Interval 10.84 to 34.11
|
—
|
—
|
—
|
|
Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
Best overall response: SD
|
32.1 percentage of participants
Interval 19.92 to 46.32
|
—
|
—
|
—
|
|
Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
Best overall response: PD
|
34.0 percentage of participants
Interval 21.52 to 48.27
|
—
|
—
|
—
|
|
Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
Best overall response: NE
|
13.2 percentage of participants
Interval 5.48 to 25.34
|
—
|
—
|
—
|
|
Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
Response rate (CR or PR)
|
20.8 percentage of participants
Interval 10.84 to 34.11
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).Population: ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Clinical benefit was defined as CR, PR or SD lasting at least 12 weeks using centrally or locally assessed RECIST v1.1.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Clinical Benefit (All Cohorts).
Clinical benefit (centrally assessed)
|
26.4 percentage of participants
Interval 15.26 to 40.33
|
20.0 percentage of participants
Interval 10.43 to 32.97
|
15.8 percentage of participants
Interval 6.02 to 31.25
|
0.0 percentage of participants
No patients derived clinical benefit, unable to compute 95% CI.
|
|
Clinical Benefit (All Cohorts).
Clinical benefit (locally assessed)
|
32.1 percentage of participants
Interval 19.92 to 46.32
|
16.4 percentage of participants
Interval 7.77 to 28.8
|
15.8 percentage of participants
Interval 6.02 to 31.25
|
0.0 percentage of participants
No patients derived clinical benefit, unable to compute 95% CI.
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression, up to 36 months.Population: ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to any cause before initiation of new systemic treatment.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
PFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
|
15.71 Weeks
Interval 8.0 to 16.43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).Population: ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally and locally assessed RECIST v1.1 (i.e. increase in tumor size ≥20%) or death due to any cause before initiation of new systemic treatment.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
PFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts).
PFS (centrally assessed)
|
15.86 Weeks
Interval 8.0 to 23.14
|
8.00 Weeks
Interval 7.71 to 17.43
|
14.86 Weeks
Interval 7.86 to 16.71
|
6.00 Weeks
Interval 5.29 to 7.29
|
|
PFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts).
PFS (locally assessed)
|
15.71 Weeks
Interval 8.0 to 16.43
|
7.57 Weeks
Interval 7.0 to 7.86
|
7.86 Weeks
Interval 7.29 to 14.71
|
5.79 Weeks
Interval 5.14 to 6.86
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression, up to 36 months.Population: ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
TTP defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to disease progression before initiation of a new systemic treatment.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Time to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort).
|
15.86 Weeks
Interval 8.43 to 16.43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).Population: ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
TTP was defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally and locally assessed RECIST v1.1 criteria (i.e. increase in tumor size ≥20%) or death due to disease progression before initiation of a new systemic treatment.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
TTP by RECIST v1.1 (All Cohorts).
TTP (centrally assessed)
|
15.86 Weeks
Interval 8.43 to 24.0
|
8.00 Weeks
Interval 7.71 to 17.43
|
14.86 Weeks
Interval 7.86 to 16.0
|
6.00 Weeks
Interval 5.29 to 7.29
|
|
TTP by RECIST v1.1 (All Cohorts).
TTP (locally assessed)
|
15.71 Weeks
Interval 8.0 to 16.43
|
7.57 Weeks
Interval 7.0 to 7.86
|
7.86 Weeks
Interval 7.29 to 14.71
|
5.79 Weeks
Interval 5.14 to 6.86
|
SECONDARY outcome
Timeframe: Time from first study treatment to death, up to 36 months.Population: ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
OS is the time (in weeks) from the first study medication date to death due to any cause. Patients were censored at the date of last contact (the latest between the time of EoST/WD assessment and follow-up visits). OS was estimated using Kaplan-Meier analysis.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Overall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts).
|
29.29 Weeks
Interval 25.0 to 38.71
|
NA Weeks
Interval 30.71 to
Median could not be calculated as there was insufficient number of participants with events.
|
32.71 Weeks
Interval 26.43 to 40.86
|
21.57 Weeks
Interval 13.86 to 33.29
|
SECONDARY outcome
Timeframe: 16 weeks, Last Patient First Treatment + 16 weeks.Population: ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.
Further systemic treatment was coded using World Health Organization (WHO) Drug Dictionary (versions: June 2014 for the hepatocellular carcinoma cohort and June 2013 for the ovarian, renal cell and gastric carcinoma cohorts). A frequency table of the number and percentage of patients was provided by Anatomical Therapeutic Chemical (ATC) decode and preferred name.
Outcome measures
| Measure |
Hepatocellular Carcinoma Cohort
n=53 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 Participants
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Further Cancer-related Treatment During Follow-up Period (All Cohorts).
|
16 Participants
|
35 Participants
|
18 Participants
|
8 Participants
|
Adverse Events
Hepatocellular Carcinoma Cohort
Serious events: 14 serious events
Other events: 53 other events
Deaths: 38 deaths
Ovarian Carcinoma Cohort
Serious events: 19 serious events
Other events: 55 other events
Deaths: 22 deaths
Renal Cell Carcinoma Cohort
Serious events: 11 serious events
Other events: 38 other events
Deaths: 22 deaths
Gastric Carcinoma Cohort
Serious events: 7 serious events
Other events: 21 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Hepatocellular Carcinoma Cohort
n=53 participants at risk
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 participants at risk
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 participants at risk
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 participants at risk
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Asthenia
|
3.8%
2/53 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Oedema peripheral
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Fatigue
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Non-cardiac chest pain
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Pyrexia
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Disease progression
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Peritonitis
|
3.8%
2/53 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Lung infection
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
2/53 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Renal and urinary disorders
Renal failure
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory myofibroblastic tumour
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/53 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Blood bilirubin increased
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Blood creatinine increased
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Cardiac disorders
Cardiac failure
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
Other adverse events
| Measure |
Hepatocellular Carcinoma Cohort
n=53 participants at risk
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Ovarian Carcinoma Cohort
n=55 participants at risk
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Renal Cell Carcinoma Cohort
n=38 participants at risk
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
Gastric Carcinoma Cohort
n=21 participants at risk
1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.
1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
|
|---|---|---|---|---|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Vascular disorders
Hypertension
|
5.7%
3/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Vascular disorders
Hypotension
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
13.2%
5/38 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Oedema peripheral
|
30.2%
16/53 • Number of events 18 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
30.9%
17/55 • Number of events 21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.5%
4/38 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Fatigue
|
58.5%
31/53 • Number of events 36 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
56.4%
31/55 • Number of events 41 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
18.4%
7/38 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
71.4%
15/21 • Number of events 18 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Asthenia
|
13.2%
7/53 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.1%
5/55 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
28.9%
11/38 • Number of events 17 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Pyrexia
|
3.8%
2/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
14.5%
8/55 • Number of events 10 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Chest pain
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Chills
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
General disorders
Influenza like illness
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Psychiatric disorders
Insomnia
|
17.0%
9/53 • Number of events 11 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
16.4%
9/55 • Number of events 10 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
15.8%
6/38 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
28.6%
6/21 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.3%
4/55 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
14.3%
3/21 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Weight decreased
|
24.5%
13/53 • Number of events 14 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
13.2%
5/38 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
28.6%
6/21 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
14.3%
3/21 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
3/53 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.9%
6/55 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Aspartate aminotransferase increased
|
7.5%
4/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.9%
6/55 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Blood bilirubin increased
|
7.5%
4/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.1%
5/55 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Lipase increased
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.9%
6/55 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Investigations
Amylase increased
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.1%
5/55 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/53 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
16.4%
9/55 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.9%
3/38 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
23.8%
5/21 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
5/53 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
21.8%
12/55 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
23.7%
9/38 • Number of events 10 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
14.3%
3/21 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.9%
10/53 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
21.8%
12/55 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.9%
3/38 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Headache
|
17.0%
9/53 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
18.2%
10/55 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.5%
4/38 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.5%
4/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Dizziness
|
3.8%
2/53 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.1%
5/55 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.5%
4/38 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
13.2%
5/38 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Dysgeusia
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.3%
15/53 • Number of events 17 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
34.5%
19/55 • Number of events 20 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
21.1%
8/38 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
42.9%
9/21 • Number of events 11 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Nausea
|
39.6%
21/53 • Number of events 28 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
43.6%
24/55 • Number of events 30 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
31.6%
12/38 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
61.9%
13/21 • Number of events 17 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
34.0%
18/53 • Number of events 25 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
29.1%
16/55 • Number of events 21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
23.7%
9/38 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
61.9%
13/21 • Number of events 18 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Constipation
|
28.3%
15/53 • Number of events 16 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
21.8%
12/55 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
34.2%
13/38 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
52.4%
11/21 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
23.8%
5/21 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.1%
5/55 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
19.0%
4/21 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.4%
14/53 • Number of events 20 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
25.5%
14/55 • Number of events 18 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
18.4%
7/38 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
14.3%
3/21 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.5%
4/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
18.2%
10/55 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.2%
7/53 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
23.6%
13/55 • Number of events 14 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Ascites
|
9.4%
5/53 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Dysphagia
|
5.7%
3/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
2/53 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
3/53 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.9%
3/38 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/53 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.9%
3/38 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.3%
4/55 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.9%
3/38 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.9%
3/38 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.9%
3/38 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.0%
9/53 • Number of events 11 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
25.5%
14/55 • Number of events 15 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
13.2%
5/38 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
52.4%
11/21 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
4/53 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.1%
5/55 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.5%
4/38 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
19.0%
4/21 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.8%
2/53 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
5/53 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
18.2%
10/55 • Number of events 11 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.3%
2/38 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
14.3%
3/21 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.7%
3/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.3%
4/55 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.5%
4/38 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
2/53 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.9%
6/55 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.5%
4/38 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.5%
4/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.7%
3/53 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
39.6%
21/53 • Number of events 22 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
36.4%
20/55 • Number of events 25 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
28.9%
11/38 • Number of events 11 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
71.4%
15/21 • Number of events 17 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/53 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.8%
2/53 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
10.9%
6/55 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.3%
4/55 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
4.8%
1/21 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
13.2%
5/38 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
14.3%
3/21 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Oral candidiasis
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
14.3%
3/21 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
12.7%
7/55 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
9.5%
2/21 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Rash pustular
|
7.5%
4/53 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/38 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
|
Infections and infestations
Bronchitis
|
5.7%
3/53 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
2.6%
1/38 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
0.00%
0/21 • Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.
Tumour-related signs and symptoms were reported as TEAEs during the study only if they worsened in severity or increased in frequency. Natural progression/deterioration of the malignancy and disease progression that led to death were recorded as part of the efficacy evaluation. The Safety population comprised all patients who had received at least one dose of tasquinimod. AEs were coded using MedDRA 17.1 for the Hepatocellular Carcinoma cohort and version 16.1 for all other cohorts.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor required reasonable opportunity to review any abstract, presentation, or paper before the material was submitted for publication or communicated. This also applied to any amendments that were requested by referees or journal editors. The Sponsor committed to comment on the draft documents within a time period agreed in the contractual arrangements between the Sponsor and authors or their institution. Delays were also possible if publication would adversely affect patentability.
- Publication restrictions are in place
Restriction type: OTHER