Trial Outcomes & Findings for Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study (NCT NCT04400474)
NCT ID: NCT04400474
Last Updated: 2025-06-19
Results Overview
Radiological objective response rate (ORR) evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan ORR= CR (confirmed complete response) + PR (confirmed partial response) as best response PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Through study completion, average 1 year
Results posted on
2025-06-19
Participant Flow
Participant milestones
| Measure |
LungNET (Lung Typical and Atypical Carcinoids)
Lung typical and atypical carcinoids Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ATC (Anaplastic Thyroid Cancer)
ATC in first-line or after PD to chemotherapy or investigational drugs Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ACC (Adrenocortical Carcinoma)
ACC after PD to chemotherapy and/or mitotane Cabozantinib 40 mg + Atezolizumab 1200 mg
|
PPGL (Pheochromocytoma/Paraganglioma)
malignant PPGL (pheochromocytoma/paraganglioma) after PD to PRRT if indicated, prior chemotherapy and/or SSAs.
Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET)
G1-2 GEP-NET, grade 1-2 gastroenteropancreatic NET Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.)
G3 EP-NEN, grade 3 extrapulmonary neuroendocrine neoplasms. Cabozantinib 40 mg + Atezolizumab 1200 mg
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
14
|
24
|
13
|
24
|
9
|
|
Overall Study
COMPLETED
|
9
|
14
|
24
|
13
|
24
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study
Baseline characteristics by cohort
| Measure |
LungNET (Lung Typical Andatypical Carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=9 Participants
LungNET, Lung typical and atypical carcinoids Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ATC (Anaplastic Thyroid Cancer) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=14 Participants
ATC in first-line or after PD to chemotherapy or investigational drugs Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ACC (Adrenocortical Carcinoma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=24 Participants
ACC after PD to chemotherapy and/or mitotane Cabozantinib 40 mg + Atezolizumab 1200 mg
|
PPGL (Pheochromocytoma/Paraganglioma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=13 Participants
malignant PPGL (pheochromocytoma/paraganglioma) after PD to PRRT if indicated, prior chemotherapy and/or SSAs.
Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET)
n=24 Participants
G1-2 GEP-NET, grade 1-2 gastroenteropancreatic NET Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.)
n=9 Participants
G3 EP-NEN, grade 3 extrapulmonary neuroendocrine neoplasms. Cabozantinib 40 mg + Atezolizumab 1200 mg
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Age at inclusion
|
63 years
n=99 Participants
|
61.5 years
n=107 Participants
|
50.5 years
n=206 Participants
|
48.0 years
n=7 Participants
|
59.5 years
n=31 Participants
|
62.0 years
n=30 Participants
|
59.0 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
49 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
44 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
91 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race · African
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Through study completion, average 1 yearPopulation: Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function.
Radiological objective response rate (ORR) evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan ORR= CR (confirmed complete response) + PR (confirmed partial response) as best response PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Outcome measures
| Measure |
LungNET (Lung Typical Andatypical Carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=9 Participants
LungNET (Lung typical andatypical carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ATC (Anaplastic Thyroid Cancer) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=14 Participants
ATC in first-line or after PD to chemotherapy or investigational drugs Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ACC (Adrenocortical Carcinoma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=24 Participants
ACC after PD to chemotherapy and/or mitotane Cabozantinib 40 mg + Atezolizumab 1200 mg
|
PPGL (Pheochromocytoma/Paraganglioma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=13 Participants
malignant PPGL (pheochromocytoma/paraganglioma) after PD to PRRT if indicated, prior chemotherapy and/or SSAs.
Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET)
n=24 Participants
G1-2 GEP-NET, grade 1-2 gastroenteropancreatic NET Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.)
n=9 Participants
G3 EP-NEN, grade 3 extrapulmonary neuroendocrine neoplasms. Cabozantinib 40 mg + Atezolizumab 1200 mg
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: TRAEs reported through clinical, up to 100 days after finishing or discontinuing treatment, on average 10 monthsPopulation: Patients with advanced and refractory endocrine and neuroendocrine neoplasms, Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function
Number of patients adverse events reaction (TRAEs) related to Cabozantinib
Outcome measures
| Measure |
LungNET (Lung Typical Andatypical Carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=9 Participants
LungNET (Lung typical andatypical carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ATC (Anaplastic Thyroid Cancer) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=14 Participants
ATC in first-line or after PD to chemotherapy or investigational drugs Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ACC (Adrenocortical Carcinoma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=24 Participants
ACC after PD to chemotherapy and/or mitotane Cabozantinib 40 mg + Atezolizumab 1200 mg
|
PPGL (Pheochromocytoma/Paraganglioma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=13 Participants
malignant PPGL (pheochromocytoma/paraganglioma) after PD to PRRT if indicated, prior chemotherapy and/or SSAs.
Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET)
n=24 Participants
G1-2 GEP-NET, grade 1-2 gastroenteropancreatic NET Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.)
n=9 Participants
G3 EP-NEN, grade 3 extrapulmonary neuroendocrine neoplasms. Cabozantinib 40 mg + Atezolizumab 1200 mg
|
|---|---|---|---|---|---|---|
|
Safety Profile Number of Adverse Events Reactions (TRAEs)
|
8 Participants
|
11 Participants
|
18 Participants
|
11 Participants
|
22 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: TRAEs reported through clinical, up to 100 days after finishing or discontinuing treatment, on average 10 monthsPopulation: Patients with advanced and refractory endocrine and neuroendocrine neoplasms. Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function.
Number of patients with adverse events reaction related to Atezolizumab as assessed by CTCAE v4.0
Outcome measures
| Measure |
LungNET (Lung Typical Andatypical Carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=9 Participants
LungNET (Lung typical andatypical carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ATC (Anaplastic Thyroid Cancer) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=14 Participants
ATC in first-line or after PD to chemotherapy or investigational drugs Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ACC (Adrenocortical Carcinoma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=24 Participants
ACC after PD to chemotherapy and/or mitotane Cabozantinib 40 mg + Atezolizumab 1200 mg
|
PPGL (Pheochromocytoma/Paraganglioma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=13 Participants
malignant PPGL (pheochromocytoma/paraganglioma) after PD to PRRT if indicated, prior chemotherapy and/or SSAs.
Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET)
n=24 Participants
G1-2 GEP-NET, grade 1-2 gastroenteropancreatic NET Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.)
n=9 Participants
G3 EP-NEN, grade 3 extrapulmonary neuroendocrine neoplasms. Cabozantinib 40 mg + Atezolizumab 1200 mg
|
|---|---|---|---|---|---|---|
|
Safety Profile Number of Adverse Events Reactions (TRAEs) Related With Atezolizumab
|
7 Participants
|
7 Participants
|
15 Participants
|
10 Participants
|
21 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From date of first documented clinical response (PR, CR) until the date of first documented progression, date of death from any cause or patient withdrawal, whichever came first, assessed up to 36 monthsPopulation: Patients with advanced and refractory endocrine and neuroendocrine neoplasms. Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function.
the time from the date of first documented CR or PR to the first documented progression or death due to underlying cancer. DoR will be determined based on tumour assessment (RECIST version 1.1 criteria).
Outcome measures
| Measure |
LungNET (Lung Typical Andatypical Carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=14 Participants
LungNET (Lung typical andatypical carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ATC (Anaplastic Thyroid Cancer) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=24 Participants
ATC in first-line or after PD to chemotherapy or investigational drugs Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ACC (Adrenocortical Carcinoma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=13 Participants
ACC after PD to chemotherapy and/or mitotane Cabozantinib 40 mg + Atezolizumab 1200 mg
|
PPGL (Pheochromocytoma/Paraganglioma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=24 Participants
malignant PPGL (pheochromocytoma/paraganglioma) after PD to PRRT if indicated, prior chemotherapy and/or SSAs.
Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET)
G1-2 GEP-NET, grade 1-2 gastroenteropancreatic NET Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.)
G3 EP-NEN, grade 3 extrapulmonary neuroendocrine neoplasms. Cabozantinib 40 mg + Atezolizumab 1200 mg
|
|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
20.4 months
Interval 11.5 to 20.9
|
13.1 months
Interval 5.4 to 20.9
|
12.2 months
Interval 5.5 to 19.0
|
15.8 months
Interval 10.6 to 20.2
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression, date of death from any cause or patient withdrawal, whichever came first, assessed up to 36 monthsPopulation: Patients with advanced and refractory endocrine and neuroendocrine neoplasms. Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function.
Median Progression free survival (mPFS) is defined as the time from the date of inclusion to the date of the first documented disease progression or death due to any cause, whichever occurs first. PFS will be determined based on tumour assessment (RECIST version 1.1 criteria). The local Investigator's assessments will be used for analyses.
Outcome measures
| Measure |
LungNET (Lung Typical Andatypical Carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=9 Participants
LungNET (Lung typical andatypical carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ATC (Anaplastic Thyroid Cancer) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=14 Participants
ATC in first-line or after PD to chemotherapy or investigational drugs Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ACC (Adrenocortical Carcinoma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=24 Participants
ACC after PD to chemotherapy and/or mitotane Cabozantinib 40 mg + Atezolizumab 1200 mg
|
PPGL (Pheochromocytoma/Paraganglioma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=13 Participants
malignant PPGL (pheochromocytoma/paraganglioma) after PD to PRRT if indicated, prior chemotherapy and/or SSAs.
Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET)
n=24 Participants
G1-2 GEP-NET, grade 1-2 gastroenteropancreatic NET Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.)
n=9 Participants
G3 EP-NEN, grade 3 extrapulmonary neuroendocrine neoplasms. Cabozantinib 40 mg + Atezolizumab 1200 mg
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
8.4 months
Interval 7.7 to
95% Confidence Interval is not reached due insufficient number of participants with events
|
4.1 months
Interval 2.7 to
95% Confidence Interval is not reached due insufficient number of participants with events
|
2.9 months
Interval 2.8 to 5.7
|
8.6 months
Interval 5.7 to
95% Confidence Interval is not reached due insufficient number of participants with events
|
13 months
Interval 11.3 to
95% Confidence Interval is not reached due insufficient number of participants with events
|
2.7 months
Interval 2.6 to
95% Confidence Interval is not reached due insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Through study period, up to 3 years after completing treatmentMedian Overall Survival (mOS) is calculated as the time from date of inclusion to date of death due to any cause.
Outcome measures
| Measure |
LungNET (Lung Typical Andatypical Carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=9 Participants
LungNET (Lung typical andatypical carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ATC (Anaplastic Thyroid Cancer) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=14 Participants
ATC in first-line or after PD to chemotherapy or investigational drugs Cabozantinib 40 mg + Atezolizumab 1200 mg
|
ACC (Adrenocortical Carcinoma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=24 Participants
ACC after PD to chemotherapy and/or mitotane Cabozantinib 40 mg + Atezolizumab 1200 mg
|
PPGL (Pheochromocytoma/Paraganglioma) Cabozantinib 40 mg + Atezolizumab 1200 mg
n=13 Participants
malignant PPGL (pheochromocytoma/paraganglioma) after PD to PRRT if indicated, prior chemotherapy and/or SSAs.
Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET)
n=24 Participants
G1-2 GEP-NET, grade 1-2 gastroenteropancreatic NET Cabozantinib 40 mg + Atezolizumab 1200 mg
|
G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.)
n=9 Participants
G3 EP-NEN, grade 3 extrapulmonary neuroendocrine neoplasms. Cabozantinib 40 mg + Atezolizumab 1200 mg
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
not reached
|
6.1 months
Interval 4.4 to
not reached
|
13.5 months
Interval 9.2 to
not reached
|
26.7 months
Interval 9.7 to
not reached
|
NA months
not reached
|
5.4 months
Interval 3.6 to
not reached
|
Adverse Events
Advanced and Refractory Endocrine and Neuroendocrine Neoplasms
Serious events: 43 serious events
Other events: 91 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Advanced and Refractory Endocrine and Neuroendocrine Neoplasms
n=93 participants at risk
Advanced and refractory endocrine and neuroendocrine neoplasms in 6 independent cohorts: well-differentiated neuroendocrine tumors (NET) of the lung (lungNET), anaplastic thyroid cancer (ATC), adrenocortical carcinoma (ACC), pheochromocytoma/paraganglioma (PPGL), well-differentiated gastroenteropancreatic NET (GEP-NET), and grade 3 extrapulmonary neuroendocrine neoplasms (G3 EP-NEN). All patients received atezolizumab 1200 mg IV Q3W plus cabozantinib 40 mg/day PO until disease progression or unacceptable toxicity.
IMPORTANT: Adverse events were collected irrespective to the Arm/Group
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
7/93 • Number of events 8 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
General disorders
Fever
|
4.3%
4/93 • Number of events 4 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
2/93 • Number of events 2 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Investigations
Alanine amino transferanse increased
|
3.2%
3/93 • Number of events 3 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Investigations
Aspatate amino ransferanse increased
|
3.2%
3/93 • Number of events 3 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/93 • Number of events 2 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Constipation
|
2.2%
2/93 • Number of events 2 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Endocrine disorders
urinary tract infection
|
2.2%
2/93 • Number of events 2 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.2%
2/93 • Number of events 2 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Endocrine disorders
adrenal insufficiency
|
2.2%
2/93 • Number of events 2 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Hepatobiliary disorders
Hepatic failure
|
2.2%
2/93 • Number of events 2 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.2%
2/93 • Number of events 2 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
General disorders
Fatigue
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
General disorders
Edema limbs
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
General disorders
Pain
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Endocrine disorders
Hyperthyroidism
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Nervous system disorders
Myasthenia gravis
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Typhlitis
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Cardiac disorders
Chest pain - cardiac
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Psychiatric disorders
Confusion
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Cardiac disorders
Heart failure
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Endocrine disorders
Hypophysitis
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Vascular disorders
Hypotension
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Infections and infestations
Meningitis
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Pancreatitis
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Infections and infestations
Sepsis
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.2%
3/93 • Number of events 3 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Nervous system disorders
Spinal cord compression
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Vascular disorders
Thromboembolic event
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.2%
2/93 • Number of events 2 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Renal and urinary disorders
Lithiasis
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Infections and infestations
Covid-19 infection
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Rectal fistula
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Infections and infestations
Small intestine infection
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Nervous system disorders
stroke
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Nervous system disorders
Hemiplegia
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Surgical and medical procedures
Spinal cord compression surgery
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain metastases
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.1%
1/93 • Number of events 1 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
Other adverse events
| Measure |
Advanced and Refractory Endocrine and Neuroendocrine Neoplasms
n=93 participants at risk
Advanced and refractory endocrine and neuroendocrine neoplasms in 6 independent cohorts: well-differentiated neuroendocrine tumors (NET) of the lung (lungNET), anaplastic thyroid cancer (ATC), adrenocortical carcinoma (ACC), pheochromocytoma/paraganglioma (PPGL), well-differentiated gastroenteropancreatic NET (GEP-NET), and grade 3 extrapulmonary neuroendocrine neoplasms (G3 EP-NEN). All patients received atezolizumab 1200 mg IV Q3W plus cabozantinib 40 mg/day PO until disease progression or unacceptable toxicity.
IMPORTANT: Adverse events were collected irrespective to the Arm/Group
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
14.0%
13/93 • Number of events 23 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Abdominal pain
|
23.7%
22/93 • Number of events 26 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Infections and infestations
Infections and infestations - Other, specify
|
16.1%
15/93 • Number of events 18 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
General disorders
Fever
|
12.9%
12/93 • Number of events 16 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
9.7%
9/93 • Number of events 10 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Diarrhea
|
47.3%
44/93 • Number of events 100 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Investigations
Aspartate aminotransferase increased
|
39.8%
37/93 • Number of events 82 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Investigations
Alanine aminotransferase increased
|
36.6%
34/93 • Number of events 81 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Vomiting
|
22.6%
21/93 • Number of events 41 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Gastrointestinal disorders
Constipation
|
14.0%
13/93 • Number of events 13 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Infections and infestations
Urinary tract infection
|
6.5%
6/93 • Number of events 8 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
General disorders
Fatigue
|
72.0%
67/93 • Number of events 167 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Investigations
Investigations - Other, specify
|
23.7%
22/93 • Number of events 94 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
15.1%
14/93 • Number of events 18 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.7%
9/93 • Number of events 11 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.6%
8/93 • Number of events 15 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
General disorders
Edema limbs
|
6.5%
6/93 • Number of events 7 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
5/93 • Number of events 5 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
|
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General disorders
Pain
|
5.4%
5/93 • Number of events 5 • Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years
The SAE definition and reporting requirements are in accordance with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Topic E2A. The grade of adverse event will be coded according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0 scoring system
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place