Trial Outcomes & Findings for Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial (NCT NCT03753919)
NCT ID: NCT03753919
Last Updated: 2026-03-11
Results Overview
6-months progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at 24 weeks after durvalumab plus tremelimumab was started without observing disease progression or death at this time point. Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression disease. For non-target lesions, CR: Disappearance of all non-target lesions; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Throughout the study period, up to 6 months from start of treatment
Results posted on
2026-03-11
Participant Flow
Participant milestones
| Measure |
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
COHORT 3: Advanced Anaplastic Thyroid Cancer (ATC)
Patients with locally advanced or metastatic anaplastic thyroid cancer regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
30
|
12
|
|
Overall Study
COMPLETED
|
37
|
30
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
COHORT 3: Advanced Anaplastic Thyroid Cancer (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid cancer regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
n=37 Participants
|
58 years
n=30 Participants
|
71 years
n=12 Participants
|
66 years
n=79 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=37 Participants
|
10 Participants
n=30 Participants
|
6 Participants
n=12 Participants
|
42 Participants
n=79 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=37 Participants
|
20 Participants
n=30 Participants
|
6 Participants
n=12 Participants
|
37 Participants
n=79 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
37 Participants
n=37 Participants
|
30 Participants
n=30 Participants
|
12 Participants
n=12 Participants
|
79 Participants
n=79 Participants
|
|
ECOG, n (%)
o
|
12 Participants
n=37 Participants
|
14 Participants
n=30 Participants
|
4 Participants
n=12 Participants
|
30 Participants
n=79 Participants
|
|
ECOG, n (%)
1
|
25 Participants
n=37 Participants
|
16 Participants
n=30 Participants
|
8 Participants
n=12 Participants
|
49 Participants
n=79 Participants
|
|
Type of previous lines, n (%)
Chemotherapy
|
2 Participants
n=37 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=12 Participants
|
10 Participants
n=79 Participants
|
|
Histopathological grade; n (%)
Well differentiated
|
12 Participants
n=37 Participants
|
6 Participants
n=30 Participants
|
0 Participants
n=12 Participants
|
18 Participants
n=79 Participants
|
|
Histopathological grade; n (%)
Poorly differentiated
|
10 Participants
n=37 Participants
|
1 Participants
n=30 Participants
|
11 Participants
n=12 Participants
|
22 Participants
n=79 Participants
|
|
Histopathological grade; n (%)
Unknown
|
15 Participants
n=37 Participants
|
23 Participants
n=30 Participants
|
1 Participants
n=12 Participants
|
39 Participants
n=79 Participants
|
|
Previous surgery, n (%)
Yes
|
35 Participants
n=37 Participants
|
27 Participants
n=30 Participants
|
2 Participants
n=12 Participants
|
64 Participants
n=79 Participants
|
|
Previous surgery, n (%)
No
|
2 Participants
n=37 Participants
|
3 Participants
n=30 Participants
|
10 Participants
n=12 Participants
|
15 Participants
n=79 Participants
|
|
Previous radiotherapy, n (%)
Yes
|
33 Participants
n=37 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=12 Participants
|
35 Participants
n=79 Participants
|
|
Previous radiotherapy, n (%)
No
|
4 Participants
n=37 Participants
|
28 Participants
n=30 Participants
|
12 Participants
n=12 Participants
|
44 Participants
n=79 Participants
|
|
Previous systemic lines, n (%)
0
|
0 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
7 Participants
n=12 Participants
|
7 Participants
n=79 Participants
|
|
Previous systemic lines, n (%)
1
|
12 Participants
n=37 Participants
|
20 Participants
n=30 Participants
|
0 Participants
n=12 Participants
|
32 Participants
n=79 Participants
|
|
Previous systemic lines, n (%)
2
|
17 Participants
n=37 Participants
|
9 Participants
n=30 Participants
|
5 Participants
n=12 Participants
|
31 Participants
n=79 Participants
|
|
Previous systemic lines, n (%)
≥ 3
|
8 Participants
n=37 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=12 Participants
|
9 Participants
n=79 Participants
|
|
Type of previous lines, n (%)
Lenvatinib
|
34 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=12 Participants
|
36 Participants
n=79 Participants
|
|
Type of previous lines, n (%)
Sorafenib
|
25 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=12 Participants
|
25 Participants
n=79 Participants
|
|
Type of previous lines, n (%)
Vandetanib
|
2 Participants
n=37 Participants
|
30 Participants
n=30 Participants
|
0 Participants
n=12 Participants
|
32 Participants
n=79 Participants
|
|
Type of previous lines, n (%)
Cabozantinib
|
1 Participants
n=37 Participants
|
7 Participants
n=30 Participants
|
0 Participants
n=12 Participants
|
8 Participants
n=79 Participants
|
|
Type of previous lines, n (%)
RET inhibitors
|
1 Participants
n=37 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=79 Participants
|
|
Type of previous lines, n (%)
Other BRAF / MEK inhibitor
|
2 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=12 Participants
|
4 Participants
n=79 Participants
|
|
Type of previous lines, n (%)
Other MKIs
|
4 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=79 Participants
|
PRIMARY outcome
Timeframe: Throughout the study period, up to 6 months from start of treatmentPopulation: Patients with progressive, refractory advanced thyroid carcinoma
6-months progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at 24 weeks after durvalumab plus tremelimumab was started without observing disease progression or death at this time point. Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression disease. For non-target lesions, CR: Disappearance of all non-target lesions; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Progression-free Survival Rate at 6 Months
|
33.3 percentage of patients
Interval 15.0 to 74.2
|
32.4 percentage of patients
Interval 20.4 to 51.6
|
40.9 percentage of patients
Interval 26.3 to 63.6
|
PRIMARY outcome
Timeframe: Throughout the trial period, up to 6 months from first dose of treatment.Population: Patients with progressive, refractory advanced thyroid carcinoma
Defined as percentage of patients alive at month 6 from first dose of treatment.
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Overall Survival Rate at 6 Months
|
65.6 percentage of patients
Interval 43.2 to 99.8
|
70.3 percentage of patients
Interval 56.7 to 86.7
|
96.6 percentage of patients
Interval 90.1 to 100.0
|
SECONDARY outcome
Timeframe: Throughout the trial period, with a following up to 4 years from the start of treatmentPopulation: Patients with progressive, refractory advanced thyroid carcinoma
Median OS, defined as the time from the start of treatment until death (patients without events were censored at the last follow-up). Estimated by Kaplan-Meier
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Overall Survival, Median
|
13.8 months
Interval 5.7 to
95% Confidence Interval is not reached due insufficient number of participants with events
|
13.8 months
Interval 9.4 to 32.8
|
35.5 months
Interval 30.1 to
95% Confidence Interval is not reached due insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Throughout the trial period, up to 18 months from first dose of treatment.Population: Patients with progressive, refractory advanced thyroid carcinoma
Percentage of patients alive at month 18 from first dose of treatment.
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Overall Survival Rate at 18 Months
|
46.9 percentage of patients
Interval 25.0 to 87.9
|
41.5 percentage of patients
Interval 28.0 to 61.4
|
78.8 percentage of patients
Interval 65.3 to 97.5
|
SECONDARY outcome
Timeframe: Throughout the trial period, a median follow-up period 14 months from the start of treatmentPopulation: Patients with progressive, refractory advanced thyroid carcinoma
median PFS, defined as the time from the start of treatment until disease progression (PD) according to RECIST v1.1 or death (patients without events were censored at the last tumor assessment). Estimated by Kaplan-Meier. Per RECIST v1.1, PD: for target lesions, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. For non-target lesions: unequivocal progression of existing non-target lesions or appearance of new lesions.
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Progression-free Survival (PFS), Median
|
3.6 months
Interval 2.2 to
95% Confidence Interval is not reached due insufficient number of participants with events
|
3.7 months
Interval 2.7 to 6.5
|
5.3 months
Interval 2.8 to 23.2
|
SECONDARY outcome
Timeframe: Throughout the study period, up to 18 months from start of treatmentPopulation: Patients with progressive, refractory advanced thyroid carcinoma
18-months progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at 18 months after durvalumab plus tremelimumab was started without observing disease progression or death at this time point. Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression disease. For non-target lesions, CR: Disappearance of all non-target lesions; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Progression-free Survival Rate at 18 Months
|
8.3 percentage of patients
Interval 1.3 to 54.4
|
6.0 percentage of patients
Interval 1.6 to 22.6
|
26.5 percentage of patients
Interval 13.6 to 51.6
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearPopulation: Patients with progressive, refractory advanced thyroid carcinoma
Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to RECIST 1.1 criteria or iRECIST 1.1 criteria
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Overall Response Rate (ORR)
|
33 percentage of patients
|
8 percentage of patients
|
10 percentage of patients
|
SECONDARY outcome
Timeframe: Throughout the trial period, with a following up to 4 years from the start of treatmentPopulation: Patients with progressive, refractory advanced thyroid carcinoma
Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to RECIST 1.1 criteria Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions, CR: Disappearance of all non-target lesions.
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Overall Response (OR) Best Response According to RECIST 1.1
PD
|
41.7 percentage of patients
|
29.7 percentage of patients
|
36.7 percentage of patients
|
|
Overall Response (OR) Best Response According to RECIST 1.1
PR
|
33.3 percentage of patients
|
8.1 percentage of patients
|
10.0 percentage of patients
|
|
Overall Response (OR) Best Response According to RECIST 1.1
CR
|
0.0 percentage of patients
|
0.0 percentage of patients
|
0.0 percentage of patients
|
|
Overall Response (OR) Best Response According to RECIST 1.1
Unknown
|
0 percentage of patients
|
13.5 percentage of patients
|
3.3 percentage of patients
|
|
Overall Response (OR) Best Response According to RECIST 1.1
SD
|
25.0 percentage of patients
|
48.6 percentage of patients
|
50.0 percentage of patients
|
SECONDARY outcome
Timeframe: Throughout the trial period, with a following up to 4 years from the start of treatmentPopulation: Patients with progressive, refractory advanced thyroid carcinoma
Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to irRecist criteria.
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Overall Response (OR) Best Response According irRecist Criteria
PR
|
25.0 percentage of patients
|
8.1 percentage of patients
|
10.0 percentage of patients
|
|
Overall Response (OR) Best Response According irRecist Criteria
CR
|
8.3 percentage of patients
|
0.0 percentage of patients
|
0.0 percentage of patients
|
|
Overall Response (OR) Best Response According irRecist Criteria
Not evaluable
|
8.3 percentage of patients
|
2.7 percentage of patients
|
0 percentage of patients
|
|
Overall Response (OR) Best Response According irRecist Criteria
PD
|
33.3 percentage of patients
|
27.0 percentage of patients
|
33.3 percentage of patients
|
|
Overall Response (OR) Best Response According irRecist Criteria
SD
|
25.0 percentage of patients
|
48.6 percentage of patients
|
53.3 percentage of patients
|
|
Overall Response (OR) Best Response According irRecist Criteria
Unknown
|
0 percentage of patients
|
13.5 percentage of patients
|
3.3 percentage of patients
|
SECONDARY outcome
Timeframe: Through study period, assessed up to 4 yearsPopulation: Patients with progressive, refractory advanced thyroid carcinoma
Defined as the time from the first PR/CR to disease progression or the last tumor assessment. DoR will be determined based on tumour assessment RECIST 1.1 criteria Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions, CR: Disappearance of all non-target lesions.
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=4 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=3 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=3 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Duration of Response (DoR) Median RECIST 1.1 Criteria
|
5.7 months
Interval 0.0 to 41.7
|
19.3 months
Interval 2.7 to 40.0
|
28.0 months
Interval 20.7 to 47.1
|
SECONDARY outcome
Timeframe: Through study period, assessed up to 4 yearsPopulation: Patients with progressive, refractory advanced thyroid carcinoma
Defined as the time from the first PR/CR to disease progression or the last tumor assessment. DoR will be determined based on tumour assessment according to irRECIST criteria
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=4 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=3 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=3 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Duration of Response (DoR) Median irRECIST Criteria
|
5.7 months
Interval 0.0 to 41.7
|
19.3 months
Interval 2.7 to 40.0
|
28.0 months
Interval 20.7 to 47.1
|
SECONDARY outcome
Timeframe: Throughout the study period, from start treatment up 90 days after the last dose, up to 5 years.Population: Safety Analysis Set will include all subjects who were allocated and received at least one dose of the study drug and had at least one post-baseline safety evaluation (week 12). This will be the analysis set for all safety evaluations.
Percentage of patients who presented adverse events related with study treatment throughout the study period, Toxicity will be evaluated according NCI CTCAE v 5.0 criteria. AEs and SAEs will be collected from the time of the patient signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab ± tremelimumab).
Outcome measures
| Measure |
COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC)
n=12 Participants
Patients with locally advanced or metastatic anaplastic thyroid carcinoma regardless of prior therapy. No prior therapy with immune checkpoint inhibitors is allowed
|
COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC)
n=37 Participants
Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs.
|
COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC)
n=30 Participants
Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-Related Adverse Events (TRAEs)
AE related to durvalumab
|
75.9 percentage of patients
|
67.6 percentage of patients
|
86.7 percentage of patients
|
|
Percentage of Participants With Treatment-Related Adverse Events (TRAEs)
AE related to tremelimumab
|
75.0 percentage of patients
|
62.2 percentage of patients
|
83.3 percentage of patients
|
|
Percentage of Participants With Treatment-Related Adverse Events (TRAEs)
AE related to to both treatments (Durvalumab/Tremelimumab)
|
72.2 percentage of patients
|
62.2 percentage of patients
|
83.3 percentage of patients
|
|
Percentage of Participants With Treatment-Related Adverse Events (TRAEs)
Toxicity grade >=3
|
16.7 percentage of patients
|
13.5 percentage of patients
|
26.7 percentage of patients
|
|
Percentage of Participants With Treatment-Related Adverse Events (TRAEs)
SAE
|
66.7 percentage of patients
|
70.3 percentage of patients
|
60.0 percentage of patients
|
Adverse Events
COHORT 1: Durvalumab + Tremelimumab
Serious events: 26 serious events
Other events: 35 other events
Deaths: 11 deaths
COHORT 1: Durvalumab Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
COHORT 2: Durvalumab + Tremelimumab
Serious events: 18 serious events
Other events: 30 other events
Deaths: 1 deaths
COHORT 2: Durvalumab Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
COHORT 3: Durvalumab + Tremelimumab
Serious events: 8 serious events
Other events: 11 other events
Deaths: 2 deaths
COHORT 3: Durvalumab Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
COHORT 1: Durvalumab + Tremelimumab
n=37 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 1 during durvalumab + tremelimumab treatment phase.
|
COHORT 1: Durvalumab Monotherapy
n=26 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 1 during durvalumab monotherapy treatment phase.
|
COHORT 2: Durvalumab + Tremelimumab
n=30 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 2 during durvalumab + tremelimumab treatment phase.
|
COHORT 2: Durvalumab Monotherapy
n=25 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 2 during durvalumab monotherapy treatment phase.
|
COHORT 3: Durvalumab + Tremelimumab
n=12 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 3 during durvalumab + tremelimumab treatment phase.
|
COHORT 3: Durvalumab Monotherapy
n=10 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 3 during durvalumab monotherapy treatment phase.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
10.8%
4/37 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
25.0%
3/12 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.8%
4/37 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
25.0%
3/12 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Diarrhea
|
13.5%
5/37 • Number of events 6 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
20.0%
6/30 • Number of events 8 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Fatigue
|
8.1%
3/37 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Lumbar pain
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Injury, poisoning and procedural complications
Fracture
|
10.8%
4/37 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Disease progression
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
8.1%
3/37 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Nervous system disorders
Cognitive disturbance
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
16.7%
5/30 • Number of events 5 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
16.7%
2/12 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Multi-organ failure
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Enterocolitis infectious
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Colitis
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.5%
5/37 • Number of events 5 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Renal and urinary disorders
Other, specify: Tubulointerstitial nephritis
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
Creatinine increased
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Acute interstitial nephritis
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Fever
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
COVID-19
|
8.1%
3/37 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Psychiatric disorders
Suicide attempt
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Injury, poisoning and procedural complications
Other, specify: Neurotoxicity
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Injury, poisoning and procedural complications
Other, specify: Limb injury
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Cardiac disorders
Heart failure
|
2.7%
1/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Injury, poisoning and procedural complications
Medication error
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Musculoskeletal and connective tissue disorders
Poor analgesic control
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
Serum amylase increased
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
Lipase increased
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
Alanine aminotransferas e increased
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
Aspartate aminotransferas e increased
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
Hepatitis
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Surgical and medical procedures
Benign prostatic hyperplasia surgery complication
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications -
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Renal and urinary disorders
Renal insuffeciency
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Progression disease
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
Other adverse events
| Measure |
COHORT 1: Durvalumab + Tremelimumab
n=37 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 1 during durvalumab + tremelimumab treatment phase.
|
COHORT 1: Durvalumab Monotherapy
n=26 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 1 during durvalumab monotherapy treatment phase.
|
COHORT 2: Durvalumab + Tremelimumab
n=30 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 2 during durvalumab + tremelimumab treatment phase.
|
COHORT 2: Durvalumab Monotherapy
n=25 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 2 during durvalumab monotherapy treatment phase.
|
COHORT 3: Durvalumab + Tremelimumab
n=12 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 3 during durvalumab + tremelimumab treatment phase.
|
COHORT 3: Durvalumab Monotherapy
n=10 participants at risk
Serious adverse events and treatment-related adverse events reported in patients from cohort 3 during durvalumab monotherapy treatment phase.
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
43.2%
16/37 • Number of events 16 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
33.3%
10/30 • Number of events 10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
58.3%
7/12 • Number of events 7 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.0%
10/37 • Number of events 10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
46.7%
14/30 • Number of events 14 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
25.0%
3/12 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Diarrhea
|
24.3%
9/37 • Number of events 9 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
46.7%
14/30 • Number of events 14 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
16.7%
2/12 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.0%
10/37 • Number of events 10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
16.7%
2/12 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.6%
8/37 • Number of events 8 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
13.3%
4/30 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
30.0%
9/30 • Number of events 9 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.2%
6/37 • Number of events 6 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
13.3%
4/30 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Dysphagia
|
10.8%
4/37 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
41.7%
5/12 • Number of events 5 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.2%
6/37 • Number of events 6 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
13.3%
4/30 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Fever
|
13.5%
5/37 • Number of events 5 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
10.0%
3/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
16.7%
2/12 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Neck pain
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
41.7%
5/12 • Number of events 5 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Anemia
|
18.9%
7/37 • Number of events 7 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
10.8%
4/37 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
13.3%
4/30 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
Alanine aminotransferase increased
|
10.8%
4/37 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
10.0%
3/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.5%
5/37 • Number of events 5 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
16.7%
2/12 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
GGT increased
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
13.3%
4/30 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
Lipase increased
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
16.7%
5/30 • Number of events 5 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
Urinary tract infection
|
8.1%
3/37 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
16.7%
2/12 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
3/37 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.8%
4/37 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
Creatinine increased
|
10.8%
4/37 • Number of events 4 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Nervous system disorders
Headache
|
8.1%
3/37 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Constipation
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
10.0%
3/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Cough
|
8.1%
3/37 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
10.0%
3/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Edema limbs
|
8.1%
3/37 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
10.0%
3/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Mucositis oral
|
13.5%
5/37 • Number of events 5 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/30 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
General disorders
Pain
|
8.1%
3/37 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
10.0%
3/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
COVID-19
|
8.1%
3/37 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
10.0%
3/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
10.0%
3/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Psychiatric disorders
Insomnia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
16.7%
2/12 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Investigations
Serum amylase increased
|
0.00%
0/37 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
10.0%
3/30 • Number of events 3 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
3.3%
1/30 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
8.3%
1/12 • Number of events 1 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
|
Infections and infestations
Upper respiratory infection
|
5.4%
2/37 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/26 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
6.7%
2/30 • Number of events 2 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/25 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/12 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
0.00%
0/10 • Adverse events are collected up to 90 days after the end of treatment, up to 5 years.
As established in the protocol, the safety objective was to assess the safety profile of the combined use of durvalumab plus tremelimumab in patients with advanced thyroid neoplasms. Additionally, the Investigator Brochure of durvalumab reports also the safety information of its combined use. Therefore, the Arms/Groups used here are durvalumab+tremelimumab adverse events per patient cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place