Trial Outcomes & Findings for Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer (NCT NCT02888743)
NCT ID: NCT02888743
Last Updated: 2025-07-28
Results Overview
Determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. NSCLC: The proportion of patients with response (complete response or partial response according to RECIST) will be compared for each pair-wise comparison of radiotherapy (RT)-containing therapy and control using chi- squared tests. The difference between the proportions responding will be presented with a 90% confidence interval. CRC: The proportion of patients with response will be presented with a 90% exact confidence interval.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-07-28
Participant Flow
Participants were recruited from 18 medical centers. The first participant was enrolled in August 2017 and the last in March 2019.
NSCLC: Ninety participants were randomized (30 per arm). A total of twelve participants either withdrew consent (N=5) before starting protocol therapy, were found to be ineligible (N=4), or progressed prior to starting protocol therapy (N=3) and were not included in the analysis. CRC: Twenty patients were randomized (10 per arm). One patient (Arm B) never started protocol therapy.
Participant milestones
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Druvalumab, HD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Dervalumab, LD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
10
|
10
|
|
Overall Study
Received Protocol Therapy
|
26
|
26
|
26
|
10
|
9
|
|
Overall Study
COMPLETED
|
26
|
26
|
26
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
4
|
0
|
1
|
Reasons for withdrawal
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Druvalumab, HD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Dervalumab, LD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
0
|
1
|
|
Overall Study
Disease progression before treatment
|
2
|
0
|
2
|
0
|
0
|
|
Overall Study
Patient ineligible
|
1
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
n=26 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A Tremelimumab, Durvalumab, HD-RT)
n=10 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=9 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14..
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.5 Years
n=5 Participants
|
68.0 Years
n=7 Participants
|
65.5 Years
n=5 Participants
|
58 Years
n=4 Participants
|
59 Years
n=21 Participants
|
66.0 Years
n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
88 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
78 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
26 participants
n=5 Participants
|
10 participants
n=4 Participants
|
9 participants
n=21 Participants
|
97 participants
n=8 Participants
|
|
ECOG Performance Status (PS)
0 (Fully active)
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
ECOG Performance Status (PS)
1 (Restricted in strenuous activities)
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
|
ECOG Performance Status (PS)
2 (Restricted in work; capable of self care)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Histology
Adenocarcinoma
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
|
Histology
Squamous
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Histology
Not specified
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Previous Radiotherapy
Yes
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
|
Previous Radiotherapy
No
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Previous lines of therapy
|
3 Lines of therapy
n=5 Participants
|
3 Lines of therapy
n=7 Participants
|
3 Lines of therapy
n=5 Participants
|
4 Lines of therapy
n=4 Participants
|
3 Lines of therapy
n=21 Participants
|
3 Lines of therapy
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All patients receiving at least one regimen of protocol therapy.
Determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. NSCLC: The proportion of patients with response (complete response or partial response according to RECIST) will be compared for each pair-wise comparison of radiotherapy (RT)-containing therapy and control using chi- squared tests. The difference between the proportions responding will be presented with a 90% confidence interval. CRC: The proportion of patients with response will be presented with a 90% exact confidence interval.
Outcome measures
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
n=26 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=10 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=9 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Overall Response Rate
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until objective disease progression or death, whichever occurs first [up to 2 years]Population: Patients receiving at least one regimen of protocol therapy.
Distributions are summarized using the Kaplan-Meier method. Median times for each therapy arm are accompanied by 90% confidence intervals based on log(-log(endpoint)) methodology. NSCLC: The pairwise comparisons between the durvalumab/tremelimumab alone and durvalumab/tremelimumab with RT arms will be conducted using Cox regression. CRC: No statistical comparisons conducted between Arms A and B.
Outcome measures
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
n=26 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=10 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=9 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
4.0 Months
Interval 2.1 to 7.0
|
4.6 Months
Interval 2.1 to 7.2
|
3.3 Months
Interval 1.8 to 5.5
|
1.8 Months
Interval 1.5 to 2.0
|
1.6 Months
Interval 1.3 to 1.9
|
SECONDARY outcome
Timeframe: From time of randomization to death from any cause [up to 2 years]Population: Patients receiving at least one regimen of protocol therapy.
Distributions are summarized using the method of Kaplan-Meier. Median times for each therapy arm are accompanied by 90% confidence intervals based on log(-log(endpoint)) methodology. NSCLC: The pairwise comparisons between the durvalumab/tremelimumab alone and durvalumab/tremelimumab with RT arms are conducted using Cox regression. CRC: No statistical comparisons between arms were conducted.
Outcome measures
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
n=26 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=10 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=9 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
9.7 Months
Interval 5.1 to
The upper bound of the confidence interval was not reached
|
9.1 Months
Interval 3.8 to 23.9
|
NA Months
Interval 4.9 to
The median OS and upper bound of the confidence interval were not reached.
|
3.6 Months
Interval 2.2 to 6.4
|
4.2 Months
Interval 2.1 to 5.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients receiving at least one regimen of protocol therapy.
NSCLC only: Proportions with irCR, irPR, irSD, irPD, and NA are presented with 90% exact binomial confidence intervals. The Immune-Related Response Criteria (irRC) is a set of published rules that defines when cancer tumors improve, stay the same, or worsen during treatment with an immuno-oncology drug. The response criteria are: irCR: Complete disappearance of all lesions, no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented; irPR: decrease in tumor burden \>50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later; irPD: increase in tumor burden \>25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later; irSD: not meeting criteria for irCR or irPR in the absence of irPD.
Outcome measures
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
n=26 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Objective Response Per Immune-related Response (irRC) Criteria
irCR
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Objective Response Per Immune-related Response (irRC) Criteria
irPR
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Objective Response Per Immune-related Response (irRC) Criteria
irSD
|
9 Participants
|
11 Participants
|
9 Participants
|
—
|
—
|
|
Objective Response Per Immune-related Response (irRC) Criteria
irPD
|
9 Participants
|
8 Participants
|
11 Participants
|
—
|
—
|
|
Objective Response Per Immune-related Response (irRC) Criteria
Missing/not available
|
5 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants who received at least one regimen of protocol therapy.
Assessed by Common Terminology Criteria for Adverse Events version 4.0. The proportions of subjects with grade-3 or higher adverse events (all attributions) are presented with 90% exact binomial confidence intervals.
Outcome measures
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
n=26 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=10 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=9 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Incidence of Grade 3-5 Adverse Events
|
11.5 Percentage of participants
Interval 3.0 to 27.0
|
30.8 Percentage of participants
Interval 16.0 to 49.0
|
15.4 Percentage of participants
Interval 5.0 to 32.0
|
70.0 Percentage of participants
Interval 39.0 to 91.0
|
77.8 Percentage of participants
Interval 45.0 to 96.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants receiving at least one regimen of protocol therapy.
NSCLC: Local control - Having two or more scans with RECIST response of stable disease (SD), one response of SD followed by non-confirmed PR, or a confirmed response of PR. Abscopal response occurs when a local therapy, such as radiation therapy, not only shrinks the targeted tumor(s) but also leads to the shrinkage of untreated tumors elsewhere in the body. Abscopal response is measured using RECIST criteria (proportion of patients with complete (CR) or partial (PR) response to therapy).
Outcome measures
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=26 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
n=26 Participants
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Local Control Rate and Abscopal Response Rate
Local control
|
9 Participants
|
6 Participants
|
8 Participants
|
—
|
—
|
|
Local Control Rate and Abscopal Response Rate
Abscopal response
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants in the NSCLC cohort with PD-L1 IHC evaluation. This analysis was pre-specified in the protocol to collect, analyze, and report data according to response and not by treatment Arm. Patients were classified into responders and non-responders according to RECIST criteria. PD-L1 percent was compared between these two groups of patients.
NSCLC participants only: Pre-treatment levels of PD-L1 percent will be compared according to RECIST response using Wilcoxon rank-sum testing. PD-L1 percent: The percentage of tumor cells that positively express the PD-L1 protein (programmed cell death ligand 1). Tumors that express high amounts of PD-L1 (\>50%) may respond well to checkpoint inhibitors (a type of immunotherapy drug).
Outcome measures
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=6 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=43 Participants
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Prognostic Effect of PD-L1 Expression
|
15.8 Percent expression
Standard Deviation 31.7
|
15.3 Percent expression
Standard Deviation 25.2
|
—
|
—
|
—
|
Adverse Events
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
Serious events: 9 serious events
Other events: 25 other events
Deaths: 15 deaths
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
Serious events: 11 serious events
Other events: 24 other events
Deaths: 15 deaths
NSCLC Arm C (Tremelimumab, Durvalumab)
Serious events: 8 serious events
Other events: 24 other events
Deaths: 9 deaths
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 6 deaths
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=26 participants at risk
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=26 participants at risk
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
n=26 participants at risk
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=10 participants at risk
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=9 participants at risk
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Cardiac disorders
Sinus Tachycardia
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Endocrine disorders
Adrenal insufficiency
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Eye disorders
Blurred vision
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Colitis
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Edema
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Fatigue
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Fever
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Multi-organ failure
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Pain
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Infections and infestations
Encephalitis infection
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Infections and infestations
Lung infection
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Infections and infestations
Meningitis
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Infections and infestations
Sepsis
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Injury, poisoning and procedural complications
Hip/spinal fracture
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Alanine Aminotransferase Increased
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Creatinine increased
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase Increased
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Blood Bilirubin Increased
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Hypokalemia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Metastatic primary lung cancer
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Disease To The Brain
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
20.0%
2/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hemorrhage
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.5%
3/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Death - Respiratory failure
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Skin and subcutaneous tissue disorders
Maculo-papular rash
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Vascular disorders
Hypotension
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Vascular disorders
Peripheral Ischemia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Vascular disorders
Thromboembolic event
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
Other adverse events
| Measure |
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=26 participants at risk
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=26 participants at risk
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
NSCLC Arm C (Tremelimumab, Durvalumab)
n=26 participants at risk
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Durvalumab: Given IV
Tremelimumab: Given IV
|
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
n=10 participants at risk
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
n=9 participants at risk
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Durvalumab: Given IV
Radiation Therapy: Undergo radiation therapy
Tremelimumab: Given IV
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Absolute Neutrophil Count
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
4/26 • Number of events 6 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
26.9%
7/26 • Number of events 13 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
40.0%
4/10 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
66.7%
6/9 • Number of events 15 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Decreased Hematocrit
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
33.3%
3/9 • Number of events 6 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Decreased MCHC
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Decreased RBC
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Elevated Absolute Monocyte
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Elevated Bands
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Elevated BUN
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Eosinophil Count Elevated
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Increased Monocyte Count
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Increased Neutrophils
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
20.0%
2/10 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Increased Platelets
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Increased RDW
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Blood and lymphatic system disorders
Monocyte Count Increased
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
30.0%
3/10 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
44.4%
4/9 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Endocrine disorders
Hypothyroidism
|
11.5%
3/26 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 20 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
30.0%
3/10 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Eye disorders
Diplopia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
20.0%
2/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Colitis
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
19.2%
5/26 • Number of events 12 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
6/26 • Number of events 10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
26.9%
7/26 • Number of events 15 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
26.9%
7/26 • Number of events 20 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
50.0%
5/10 • Number of events 10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Nausea
|
11.5%
3/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
26.9%
7/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
26.9%
7/26 • Number of events 12 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
50.0%
5/10 • Number of events 12 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
33.3%
3/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
4/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 6 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
40.0%
4/10 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
33.3%
3/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Chills
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Edema Limbs
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
40.0%
4/10 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Fatigue
|
42.3%
11/26 • Number of events 22 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
42.3%
11/26 • Number of events 21 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
34.6%
9/26 • Number of events 37 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
60.0%
6/10 • Number of events 12 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
55.6%
5/9 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Fever
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
20.0%
2/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Gait Disturbance
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Increased Thirst
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Non-Cardiac Chest Pain
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Opioid Overdose
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
General disorders
Pain
|
15.4%
4/26 • Number of events 11 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 6 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Immune system disorders
Cytokine Release Syndrome
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Infections and infestations
Upper Respiratory Infection
|
7.7%
2/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
2/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Injury, poisoning and procedural complications
Pigtail Cath Malfunction
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Injury, poisoning and procedural complications
Wrist Injury
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Alanine Aminotransferase Increased
|
7.7%
2/26 • Number of events 12 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Alkaline Phosphatase Increased
|
26.9%
7/26 • Number of events 18 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
23.1%
6/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
30.0%
3/10 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
44.4%
4/9 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
ALT Decreased
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Amylase Decreased
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.7%
2/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
30.0%
3/10 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
66.7%
6/9 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Blood Bilirubin Increased
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Creatinine Increased
|
11.5%
3/26 • Number of events 15 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 14 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased ALT
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased Amylase
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased BUN
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased Carbon Dioxide
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased Chloride
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased GFR
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased Hematocrit
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased Lipase
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased MCH
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased MCHC
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased MCV
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased Protein
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased RBC
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased Total Protein
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Decreased Urea Nitrogen
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Elevated Ammonia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Elevated Bands
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Elevated Carbon Dioxide
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Elevated Lactic Acid
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Elevated RDW
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Elevated WBC
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
GGT Increased
|
23.1%
6/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
30.0%
3/10 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
44.4%
4/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased ANC
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased BUN
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased GFR
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased Monocytes
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased Neutrophil
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased Prothrombin Time
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased RDW
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased Red Cell Distribution Width
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased Total Protein
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased WBC
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Increased White Blood Cells
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
INR Increased
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
LDH Increased
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Lymphocyte Count Decreased
|
15.4%
4/26 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
30.0%
3/10 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
66.7%
6/9 • Number of events 14 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Monocyte Count Increased
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Phosphorus Elevated
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Platelet Count Decreased
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
PT Increased
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Serum Amylase Increased
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Investigations
Weight Loss
|
11.5%
3/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Anorexia
|
19.2%
5/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
30.8%
8/26 • Number of events 18 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
34.6%
9/26 • Number of events 15 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
60.0%
6/10 • Number of events 10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
33.3%
3/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
30.0%
3/10 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
60.0%
6/10 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
33.3%
3/9 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 12 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
19.2%
5/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
19.2%
5/26 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
40.0%
4/10 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
44.4%
4/9 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
33.3%
3/9 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
20.0%
2/10 • Number of events 11 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.5%
3/26 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
20.0%
2/10 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.4%
4/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
50.0%
5/10 • Number of events 15 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
44.4%
4/9 • Number of events 10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.5%
3/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.5%
3/26 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
40.0%
4/10 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased Lumbar Spine
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Right-Sided
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
2/26 • Number of events 17 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 6 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Nervous system disorders
Abducens Nerve Disorder
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Nervous system disorders
Dizziness
|
19.2%
5/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 6 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 17 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 6 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Psychiatric disorders
Depression
|
7.7%
2/26 • Number of events 14 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
20.0%
2/10 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Renal and urinary disorders
Increased Urine Urobilinogen
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Renal and urinary disorders
Urine Discoloration
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
22.2%
2/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
19.2%
5/26 • Number of events 16 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
20.0%
2/10 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.5%
3/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
15.4%
4/26 • Number of events 7 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
34.6%
9/26 • Number of events 18 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
30.0%
3/10 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
44.4%
4/9 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.7%
2/26 • Number of events 11 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
20.0%
2/10 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
38.5%
10/26 • Number of events 43 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
19.2%
5/26 • Number of events 9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 17 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
3.8%
1/26 • Number of events 4 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 12 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
26.9%
7/26 • Number of events 28 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.5%
3/26 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
19.2%
5/26 • Number of events 8 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/10 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
11.1%
1/9 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Vascular disorders
Hypotension
|
11.5%
3/26 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
3.8%
1/26 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
7.7%
2/26 • Number of events 2 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 3 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
33.3%
3/9 • Number of events 5 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/26 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
10.0%
1/10 • Number of events 1 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
0.00%
0/9 • Two years
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
|
Additional Information
Anita Giobbie-Hurder, MS (Study biostatistician)
Department of Data Science, Dana-Farber Cancer Institute
Phone: 617-632-2193
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60