Trial Outcomes & Findings for Sunitinib for Advanced Thymus Cancer Following Earlier Treatment (NCT NCT01621568)
NCT ID: NCT01621568
Last Updated: 2024-09-24
Results Overview
Objective response rate (CR + PR) will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for sunitinib monotherapy in participants with advanced thymic malignancies. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
A median duration of 6 months
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2
Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle)
|
No Treatment: Weeks 5-6, Group 1; Week 3, Group 2
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
|---|---|---|
|
Treatment Week 1-4
STARTED
|
41
|
15
|
|
Treatment Week 1-4
COMPLETED
|
41
|
15
|
|
Treatment Week 1-4
NOT COMPLETED
|
0
|
0
|
|
Week 5-6 No Treatment
STARTED
|
41
|
15
|
|
Week 5-6 No Treatment
COMPLETED
|
39
|
15
|
|
Week 5-6 No Treatment
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2
Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle)
|
No Treatment: Weeks 5-6, Group 1; Week 3, Group 2
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
|---|---|---|
|
Week 5-6 No Treatment
Participant deemed ineligible and was taken off study. Did not receive treatment.
|
1
|
0
|
|
Week 5-6 No Treatment
Death
|
1
|
0
|
Baseline Characteristics
Sunitinib for Advanced Thymus Cancer Following Earlier Treatment
Baseline characteristics by cohort
| Measure |
Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2
n=41 Participants
Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
No Treatment: Weeks 5-6, Group 1; Week 3, Group 2
n=15 Participants
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
57.31 years
STANDARD_DEVIATION 11.35 • n=5 Participants
|
58.67 years
STANDARD_DEVIATION 8.76 • n=7 Participants
|
57.68 years
STANDARD_DEVIATION 10.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
15 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: A median duration of 6 monthsPopulation: 2/41 participants were not evaluable in group 1 thymoma and thymic carcinoma. 1/16 participants in group 2 thymic carcinoma were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for this outcome measure.
Objective response rate (CR + PR) will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for sunitinib monotherapy in participants with advanced thymic malignancies. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Group 1 (Thymoma Carcinoma) 50 mg/Day
n=16 Participants
Group 1 (Thymoma carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 1 (Thymic Carcinoma) 50 mg/Day
n=23 Participants
Group 1 (Thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 2 (Thymic Carcinoma Only) 50 mg/Day
n=15 Participants
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
|---|---|---|---|
|
Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma
Complete Response
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With an Objective Response (Partial Response (PR) + Complete Response (CR) for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma
Partial Response
|
6 percentage of participants
Interval 0.2 to 30.2
|
26 percentage of participants
Interval 10.2 to 48.4
|
8 percentage of participants
Interval 0.2 to 36.0
|
SECONDARY outcome
Timeframe: An average of 10 monthsPopulation: 2/41 participants were not evaluable in group 1 thymoma and thymic carcinoma. 1/16 participants in group 2 thymic carcinoma were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for this outcome measure.
Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesion, taking as reference the smallest sum on study; and the appearance of one or more new lesions.
Outcome measures
| Measure |
Group 1 (Thymoma Carcinoma) 50 mg/Day
n=16 Participants
Group 1 (Thymoma carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 1 (Thymic Carcinoma) 50 mg/Day
n=23 Participants
Group 1 (Thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 2 (Thymic Carcinoma Only) 50 mg/Day
n=15 Participants
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
|---|---|---|---|
|
Progression-free Survival for Sunitinib in Participants With Relapsed or Refractory Thymoma or Thymic Carcinoma
|
8.5 Months
Interval 2.8 to 11.3
|
7.2 Months
Interval 3.4 to 15.2
|
5.0 Months
Interval 2.7 to 5.5
|
SECONDARY outcome
Timeframe: 12 months after initiation of treatmentPopulation: 2/41 participants were not evaluable in group 1 thymoma and thymic carcinoma. 1/16 participants in group 2 thymic carcinoma were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for this outcome measure.
Number of participants alive at 1 year after treatment with sunitinib.
Outcome measures
| Measure |
Group 1 (Thymoma Carcinoma) 50 mg/Day
n=16 Participants
Group 1 (Thymoma carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 1 (Thymic Carcinoma) 50 mg/Day
n=23 Participants
Group 1 (Thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 2 (Thymic Carcinoma Only) 50 mg/Day
n=15 Participants
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
|---|---|---|---|
|
Number of Participants Alive at 1 Year After Treatment With Sunitinib
|
14 Participants
|
18 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.Population: For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
Adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Group 1 (Thymoma Carcinoma) 50 mg/Day
n=41 Participants
Group 1 (Thymoma carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 1 (Thymic Carcinoma) 50 mg/Day
n=15 Participants
Group 1 (Thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 2 (Thymic Carcinoma Only) 50 mg/Day
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
|---|---|---|---|
|
Number of Grades ≥3 Adverse Events Related to Sunitinib
Grade 3
|
95 Adverse events
|
40 Adverse events
|
—
|
|
Number of Grades ≥3 Adverse Events Related to Sunitinib
Grade 4
|
6 Adverse events
|
3 Adverse events
|
—
|
|
Number of Grades ≥3 Adverse Events Related to Sunitinib
Grade 5
|
1 Adverse events
|
0 Adverse events
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.Population: 1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Group 1 (Thymoma Carcinoma) 50 mg/Day
n=41 Participants
Group 1 (Thymoma carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 1 (Thymic Carcinoma) 50 mg/Day
n=15 Participants
Group 1 (Thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
Group 2 (Thymic Carcinoma Only) 50 mg/Day
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
|---|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
|
41 Participants
|
15 Participants
|
—
|
Adverse Events
Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2
Serious events: 38 serious events
Other events: 40 other events
Deaths: 38 deaths
No Treatment: Weeks 5-6, Group 1; Week 3, Group 2
Serious events: 15 serious events
Other events: 15 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2
n=41 participants at risk
Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
No Treatment: Weeks 5-6, Group 1; Week 3, Group 2
n=15 participants at risk
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Cardiac arrest
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Creatinine increased
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Death NOS
|
92.7%
38/41 • Number of events 38 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
100.0%
15/15 • Number of events 15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Ejection fraction decreased
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Fever
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Heart failure
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Vascular disorders
Hypotension
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Lung infection
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Lymphocyte count decreased
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
20.0%
3/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Disease progression
|
14.6%
6/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Malignancy
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Paresthesia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Pericardial effusion
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Platelet count decreased
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Psychiatric disorders
Psychiatric disorders - Other, Confusion
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
Other adverse events
| Measure |
Treatment: Weeks 1-4, Group 1; Weeks 1-2, Group 2
n=41 participants at risk
Group 1 (Thymoma and thymic carcinoma) treated with sunitinib 50 mg/day, 4 weeks on, 2-weeks off (6 week cycle).
|
No Treatment: Weeks 5-6, Group 1; Week 3, Group 2
n=15 participants at risk
Group 2 (Thymic carcinoma only) treated with sunitinib 50 mg/day, 2 weeks on, 1 week off (3 week cycle).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
19.5%
8/41 • Number of events 9 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 5 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Psychiatric disorders
Agitation
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Alanine aminotransferase increased
|
48.8%
20/41 • Number of events 35 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Alkaline phosphatase increased
|
31.7%
13/41 • Number of events 17 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Immune system disorders
Allergic reaction
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.1%
7/41 • Number of events 7 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Blood and lymphatic system disorders
Anemia
|
68.3%
28/41 • Number of events 87 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
26.7%
4/15 • Number of events 9 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Anorexia
|
51.2%
21/41 • Number of events 27 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
46.7%
7/15 • Number of events 11 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Psychiatric disorders
Anxiety
|
4.9%
2/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
20.0%
3/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Aspartate aminotransferase increased
|
65.9%
27/41 • Number of events 58 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
26.7%
4/15 • Number of events 5 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Ataxia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Immune system disorders
Autoimmune disorder
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.6%
6/41 • Number of events 8 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Bladder infection
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Bloating
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Blood bilirubin increased
|
26.8%
11/41 • Number of events 18 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Blurred vision
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
CPK increased
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Cheilitis
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Chills
|
17.1%
7/41 • Number of events 7 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Psychiatric disorders
Confusion
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Constipation
|
31.7%
13/41 • Number of events 16 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
43.9%
18/41 • Number of events 23 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
33.3%
5/15 • Number of events 8 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Creatinine increased
|
9.8%
4/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
20.0%
3/15 • Number of events 31 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Psychiatric disorders
Depression
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Diarrhea
|
58.5%
24/41 • Number of events 60 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
66.7%
10/15 • Number of events 18 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Dizziness
|
12.2%
5/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Dry eye
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Dry mouth
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.2%
5/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Dysesthesia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Dysgeusia
|
41.5%
17/41 • Number of events 26 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
20.0%
3/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Dyspepsia
|
41.5%
17/41 • Number of events 22 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
40.0%
6/15 • Number of events 7 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Dysphagia
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.5%
17/41 • Number of events 21 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
20.0%
3/15 • Number of events 6 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Ear and labyrinth disorders
Ear pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Edema face
|
19.5%
8/41 • Number of events 13 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Edema limbs
|
26.8%
11/41 • Number of events 13 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
20.0%
3/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Edema trunk
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Ejection fraction decreased
|
9.8%
4/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Endocrine disorders
Endocrine disorders - Other, Hypothyroidism
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Endocrine disorders
Endocrine disorders - Other, Low testosterone
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.8%
4/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Esophageal pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Esophagitis
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Eye disorders - Other, Ptosis
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Eye disorders - Other, Floaters
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Eye disorders - Other, Light sensitivity
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Eye disorders - Other, Puffy eyes
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Eye disorders - Other, Right eye subconjunctival hemorrhage
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Eye disorders - Other, Right eye swelling
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Eye disorders - Other, Visual changes
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Facial muscle weakness
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Facial pain
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Fatigue
|
75.6%
31/41 • Number of events 79 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
46.7%
7/15 • Number of events 9 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Fever
|
19.5%
8/41 • Number of events 8 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.6%
6/41 • Number of events 8 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Flu like symptoms
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
GGT increased
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Gait disturbance
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Gastritis
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.6%
6/41 • Number of events 12 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Black stool
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Mouth Sore
|
2.4%
1/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Sore mouth
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
General disorders and administration site conditions - Other, Whole body edema
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Headache
|
29.3%
12/41 • Number of events 14 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Heart failure
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Renal and urinary disorders
Hematuria
|
9.8%
4/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Vascular disorders
Hot flashes
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.8%
4/41 • Number of events 11 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.6%
6/41 • Number of events 17 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 10 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
14.6%
6/41 • Number of events 7 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Vascular disorders
Hypertension
|
41.5%
17/41 • Number of events 21 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
26.7%
4/15 • Number of events 8 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
63.4%
26/41 • Number of events 56 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
40.0%
6/15 • Number of events 20 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.0%
9/41 • Number of events 10 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
26.7%
4/15 • Number of events 6 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
20.0%
3/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.6%
6/41 • Number of events 12 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
24.4%
10/41 • Number of events 12 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
26.7%
4/15 • Number of events 7 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
26.8%
11/41 • Number of events 21 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
26.7%
4/15 • Number of events 6 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Vascular disorders
Hypotension
|
4.9%
2/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Hypothermia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Endocrine disorders
Hypothyroidism
|
22.0%
9/41 • Number of events 10 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 8 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Infections and infestations - Other, Finger
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Infections and infestations - Other, Flu
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Infections and infestations - Other, Nose Wound
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Infections and infestations - Other, Oral Infection
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Infections and infestations - Other, Sinus
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Infections and infestations - Other, Sinus infection
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Infections and infestations - Other, Thrush
|
4.9%
2/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Infections and infestations - Other, face, eye
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Psychiatric disorders
Insomnia
|
12.2%
5/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Metabolism and nutrition disorders
Iron overload
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Lethargy
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Localized edema
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Lymphocyte count decreased
|
61.0%
25/41 • Number of events 114 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
60.0%
9/15 • Number of events 60 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Lymphocyte count increased
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Malaise
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Mucosal infection
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Mucositis oral
|
56.1%
23/41 • Number of events 44 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
53.3%
8/15 • Number of events 17 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Finger Cracking
|
2.4%
1/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Hand Cramps
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Leg cramps
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Jaw pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Plantar Fasciitis Left foot
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Nail infection
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Nail loss
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
20.0%
3/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Nausea
|
53.7%
22/41 • Number of events 32 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
53.3%
8/15 • Number of events 12 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Gastric polyps
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system disorders - Other, Bilateral feet
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Nervous system disorders - Other, Heat sensitivity
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Nervous system disorders - Other, Mild numbness left lower jaw and chin
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Nervous system disorders - Other, Neuropathy
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Nervous system disorders - Other, Wrist Drop
|
2.4%
1/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Nervous system disorders - Other, dizziness
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Neuralgia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Neutrophil count decreased
|
61.0%
25/41 • Number of events 65 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
40.0%
6/15 • Number of events 25 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
24.4%
10/41 • Number of events 13 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Oral pain
|
24.4%
10/41 • Number of events 14 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
26.7%
4/15 • Number of events 5 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Ear and labyrinth disorders
Otitis externa
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
General disorders
Pain
|
17.1%
7/41 • Number of events 17 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
4/41 • Number of events 9 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
39.0%
16/41 • Number of events 30 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
33.3%
5/15 • Number of events 10 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Palpitations
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Paresthesia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Pericardial effusion
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
20.0%
3/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Periorbital edema
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.5%
8/41 • Number of events 10 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Platelet count decreased
|
61.0%
25/41 • Number of events 66 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
66.7%
10/15 • Number of events 34 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
33.3%
5/15 • Number of events 5 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary valve disease
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.5%
8/41 • Number of events 10 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Rectal pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Bloody Stools
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Rectal Bleeding
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Kidney stone
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Renal and urinary disorders
Renal calculi
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Sinus Congestion
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Rhinitis infective
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Sinus bradycardia
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Sinus tachycardia
|
22.0%
9/41 • Number of events 9 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Sinusitis
|
12.2%
5/41 • Number of events 10 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Angioedema
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Changes color
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Color change
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Facial Redness
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Hair hypopigmentation
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Hand-foot skin reaction
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Itching (anus)
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Perianal rash.
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Rash (rectal/anus)
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Rash groin
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Rash- feet
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, change of hair color
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Yellowing
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Yellowing of palms
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, nail cracking
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Yellow skin
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Skin infection
|
14.6%
6/41 • Number of events 7 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Somnolence
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.8%
4/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
13.3%
2/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Nervous system disorders
Syncope
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Upper respiratory infection
|
12.2%
5/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Urinary tract infection
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Renal and urinary disorders
Urinary urgency
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Gastrointestinal disorders
Vomiting
|
43.9%
18/41 • Number of events 26 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
26.7%
4/15 • Number of events 8 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Eye disorders
Watering eyes
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Weight gain
|
4.9%
2/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
Weight loss
|
12.2%
5/41 • Number of events 7 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
0.00%
0/15 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Investigations
White blood cell decreased
|
63.4%
26/41 • Number of events 100 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
66.7%
10/15 • Number of events 72 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
|
Infections and infestations
Wound infection
|
0.00%
0/41 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 110 months and 28 days for the thymoma/thymic carcinoma group and 91 months and 11 days for the thymic carcinoma only group.
1/16 participants in the thymic group were deemed ineligible and was taken off study. Did not receive treatment and was not assessed for adverse events. For toxicity, histology does not make a difference and tolerability is dependent on the schedule. Hence, we combined the two parts of group 1 (thymoma and thymic carcinoma) and reported the data in two groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place