Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps (NCT NCT02134925)
NCT ID: NCT02134925
Last Updated: 2025-09-10
Results Overview
The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank-Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Week 0 to week 12
Results posted on
2025-09-10
Participant Flow
For the baseline discrepancy, we projected to enroll 120 patients originally, but only enrolled 110 in the end. Of the 110, only 102 completed the study and were evaluable for the primary endpoint. Of the 8 dropouts, 7 were cancels and 1 patient was a "withdrawal by subject".
Participant milestones
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
56
|
|
Overall Study
Received at Least One Dose of Treatment
|
53
|
50
|
|
Overall Study
COMPLETED
|
52
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Cancel
|
1
|
6
|
Baseline Characteristics
Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Baseline characteristics by cohort
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
n=52 Participants
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
n=50 Participants
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
59.5 years
n=7 Participants
|
59.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown: Patient unsure
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Performance status (PS)
0
|
49 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Performance status (PS)
1
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 to week 12The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank-Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.
Outcome measures
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
n=52 Participants
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
n=50 Participants
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)
|
1.2 IgG ratio
Interval -0.5 to 17.3
|
1.0 IgG ratio
Interval 0.4 to 1.6
|
SECONDARY outcome
Timeframe: At least one year and up to 3 yearsPopulation: Participants who completed the surveillance exams were included in this analysis.
The secondary endpoint for Part 3 will evaluate the adenoma recurrence rate from surveillance exams. The rate is defined as the percentage of participants with adenoma recurrence.
Outcome measures
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
n=48 Participants
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
n=47 Participants
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Adenoma Recurrence Rate
|
56.3 percentage of participants
|
66.0 percentage of participants
|
SECONDARY outcome
Timeframe: At week 55Population: Participants with IgG levels at week 52 and 55 are included in this analysis
The key secondary endpoint for Part 2 will assess the booster response at week 55 vs. week 52 for the vaccine as compared to placebo. The IgG ratios are summarized according to the following categories : \<1, 1-\<1.5, 1.5-\<2, and \>=2 (1-year response rate).
Outcome measures
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
n=51 Participants
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
n=44 Participants
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Booster Response
<1
|
17 Participants
|
18 Participants
|
|
Booster Response
1- <1.5
|
15 Participants
|
22 Participants
|
|
Booster Response
1.5- <2
|
2 Participants
|
2 Participants
|
|
Booster Response
>=2 (1-Year Response Rate)
|
17 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 55 weeksPopulation: Participants who completed the Vaccine Report Card are included in this analysis.
Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for redness at the injection site, swelling/induration, itching at site, and skin warmth at site.
Outcome measures
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
n=53 Participants
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
n=50 Participants
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Redness at the injection site · Yes
|
36 Participants
|
2 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Redness at the injection site · None
|
12 Participants
|
44 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Redness at the injection site · Missing
|
5 Participants
|
4 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Swelling/induration · Yes
|
30 Participants
|
0 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Swelling/induration · None
|
18 Participants
|
46 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Swelling/induration · Missing
|
5 Participants
|
4 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Itching at site · Yes
|
17 Participants
|
1 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Itching at site · None
|
31 Participants
|
45 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Itching at site · Missing
|
5 Participants
|
4 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Skin warmth at site · Yes
|
29 Participants
|
3 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Skin warmth at site · None
|
19 Participants
|
43 Participants
|
|
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Skin warmth at site · Missing
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 55 weeksPopulation: Participants who completed Vaccine Report Card are included in this analysis.
Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for pain at the injection site without touching, and tenderness (pain at the injection site with touch).
Outcome measures
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
n=53 Participants
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
n=50 Participants
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Pain at the injection site without touching · Some
|
3 Participants
|
0 Participants
|
|
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Pain at the injection site without touching · A lot
|
1 Participants
|
0 Participants
|
|
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Pain at the injection site without touching · A little
|
33 Participants
|
0 Participants
|
|
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Pain at the injection site without touching · None
|
16 Participants
|
50 Participants
|
|
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Tenderness (pain at the injection site with touch) · A lot
|
3 Participants
|
0 Participants
|
|
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Tenderness (pain at the injection site with touch) · Some
|
7 Participants
|
0 Participants
|
|
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Tenderness (pain at the injection site with touch) · A little
|
32 Participants
|
3 Participants
|
|
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Tenderness (pain at the injection site with touch) · None
|
11 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: At 12 weeksThe frequency and percentage of patients with at least a 2-fold increase in the IgG Ratio will be calculated and compared between the MUC1 vaccine and placebo. The Fisher's exact test will be used.
Outcome measures
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
n=52 Participants
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
n=50 Participants
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Number of Patients With at Least a 2-Fold Increase in the IgG Ratio
|
13 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At approximately week 156Comparisons between MUC1 and placebo will be performed using a two-sample t-test or Wilcoxon rank sum test, as appropriate. All categorical variables will be analyzed using chi-square tests or Fisher's exact test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 3 yearsMDSC levels will be correlated with anti-MUC1 antibody levels and adenoma recurrence. Descriptive statistics and simple scatter plots will be generated to review the continuous biomarker data. In addition, for continuous biomarker values, the actual and percent change in the level of each of the biomarkers from baseline to post-baseline time points will be explored within each arm using Wilcoxon signed rank tests, and paired sample t-tests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 3 yearsDescriptive statistics and simple scatter plots will be generated to review the continuous biomarker data. In addition, for continuous biomarker values, the actual and percent change in the level of each of the biomarkers from baseline to post-baseline time points will be explored within each arm using Wilcoxon signed rank tests, and paired sample t-tests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsOutcome measures
Outcome data not reported
Adverse Events
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
Serious events: 12 serious events
Other events: 51 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 8 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
n=53 participants at risk
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
n=50 participants at risk
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Seizure
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Renal calculi
|
1.9%
1/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
Other adverse events
| Measure |
Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine)
n=53 participants at risk
Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
|
Arm II (Placebo)
n=50 participants at risk
Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
9.4%
5/53 • Number of events 6 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Chest pain - cardiac
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Eye disorders
Cataract
|
1.9%
1/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Eye disorders
Eye disorders - Other, specify
|
1.9%
1/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Bloating
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Diarrhea
|
7.5%
4/53 • Number of events 5 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
3/53 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
3/53 • Number of events 4 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Rectal pain
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Stomach pain
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Edema limbs
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Fatigue
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Fever
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Flu like symptoms
|
9.4%
5/53 • Number of events 7 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
6.0%
3/50 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Injection site reaction
|
88.7%
47/53 • Number of events 150 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
20.0%
10/50 • Number of events 13 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Bronchial infection
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Eye infection
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
5.7%
3/53 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Nail infection
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Otitis media
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Paronychia
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Sinusitis
|
7.5%
4/53 • Number of events 6 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Skin infection
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Soft tissue infection
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Tooth infection
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Upper respiratory infection
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
3/53 • Number of events 4 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Alkaline phosphatase increased
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Aspartate aminotransferase increased
|
5.7%
3/53 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Cholesterol high
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Investigations - Other, specify
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 8 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Lymphocyte count decreased
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Platelet count decreased
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Weight loss
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
8.0%
4/50 • Number of events 4 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
5/53 • Number of events 6 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.7%
3/53 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.0%
9/53 • Number of events 9 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decr cerv spine
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
7.5%
4/53 • Number of events 4 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
7.5%
4/53 • Number of events 4 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 5 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Headache
|
5.7%
3/53 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Spasticity
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Depression
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Renal calculi
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Urinary frequency
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Reproductive system and breast disorders
Dyspareunia
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.0%
2/50 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/53 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.7%
3/53 • Number of events 3 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
13.2%
7/53 • Number of events 9 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 4 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
3.8%
2/53 • Number of events 2 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Hot flashes
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/50 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Hypertension
|
7.5%
4/53 • Number of events 4 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
10.0%
5/50 • Number of events 5 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Thromboembolic event
|
1.9%
1/53 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
1/50 • Number of events 1 • Up to 3 years.
All graded AEs are reported for patients who received at least 1 dose of treatment and assessed for AEs. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60